MHRA issues a medical device failure alert as all HeartStart MRx defibrillators might not deliver lifesaving shocks
According to our Medicines and Healthcare products Regulatory Agency (MHRA), certain defibrillators may fail to deliver controlled shocks, cardioversion, pacing or monitoring.
The HeartStart MRx defibrillators are manufactured by Philips Healthcare and it’s believed the fault lies with the batteries. The lifesaving medical devices could fail to turn on or reboot themselves repetitively, therefore hindering administrators from being able to deliver shocks. The device could also “fail to deliver a shock or undertake pacing” after it has been unplugged from AC mains.
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MoM hip replacements potentially causing long-lasting injuries
All Metal-on-Metal (MoM) hip replacement patients are being recalled for advice and investigation in the U.K. The Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued an updated medical device alert on 29th June 2017.
It’s estimated that 49,000 patients in the U.K. were given the MoM implants (with width of 36mm or above). The NHS notes that around 3,387 surgeries in 2010 used the 36mm (or above) MoM implants.
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Rogue surgeon who performed unnecessary mastectomies on patients jailed
“Monster” surgeon jailed for 15 years.
Former breast surgeon Ian Paterson has been jailed for 15 years after he was found guilty of unnecessary mastectomies to several patients, and was convicted of multiple counts of wounding with intent.
This is a unique case – we hope victims will find some comfort in this decision, although we know the lifelong effects of his criminal activity may never be repairable.
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Apple denies responsibility for exploding iPhone 5
Apple has categorically denied responsibility for explosions reportedly occurring with their iPhone 5 products. Several complaints have been filed against the tech giant for ‘overheating and exploding’ iPhones, with a lawsuit first on 19th January in the Philadelphia County Court of Common Pleas.
On around 22nd February 2016, Kyler Mowery was injured when his iPhone 5 reportedly exploded in his pocket, with the reason for the explosion being allegedly due to a possible defect of the phone/battery.
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VW / Audi recalls approx 600,000 Audi vehicles in the U.S. for airbag and coolant pump problems
VW and Audi’s troubles extend beyond the ongoing emissions scandal as both makers have had to recall vehicles for some fairly high-risk problems.
An estimated 576,000 vehicles and SUVs are under a recall for two problems associated with the vehicles: one is for airbag defects, which can be obviously very dangerous for road users, and the second is for coolant pumps problems that may overheat and cause fires.
Both are potentially very dangerous.
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DePuy Synthes elbow implants recalled by the MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall for radial head elbow artificial replacements amidst concerns over post-operative loosening of the device.
Manufactured by DePuy company Synthes, the implants are suspected to loosen at the stem of the implant where it joins the bone. The Straight Radial Stem and the Curved Radial Stem implants are both affected by the recall. The recall follows on from a Field Safety Notice (FSN) issued back in December 2016 by the company’s Senior Quality Assurance Manager, Anne Brisson.
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Honda may be on the brink of a recall as multiple customers come forward complaining of gas fumes in the cabin.
Many Honda customers have taken to the internet to complain of unpleasant gasoline fumes filling the cabins of their 2015, 2016 and 2017 Honda CR-Vs.
Complaining drivers and passengers are reportedly unable to withstand the strong stench whilst also fearing that respiratory problems are to follow on from coughing and burning sensations experienced when inhaled.
We all know exhaust fumes can be toxic – so this could be serious.
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BMW agree to settle $478 million (£382 million) in water-damage lawsuit
In the U.S., more than 300,000 BMW owners have been granted their portion from a $478 million (£382 million) settlement over allegations that a technical defect can cause water damage to components in some BMW vehicles.
The lawsuit claimed BMW knew about the issue for years but didn’t do anything to rectify the problem until vehicle owners reported concerns. The water damage allegedly interfered with the vehicle’s Micro Power Module which was placed under the spare tyre, and this allegedly had a knock-on effect on the lights, speedometer and windscreen wipers.
The fact that the module reportedly wasn’t isolated can make the electronic component vulnerable when in contact with liquids.
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Johnson & Johnson pay out £85 million to woman who blamed ovarian cancer on their talcum powder
Medical device and pharmaceutical manufacturer Johnson & Johnson seem to be paying out lawsuit after lawsuit these days.
Being in the industry they’re in, you could expect a lot of claims, but the lawsuits Johnson & Johnson have faced over the past few years have been huge.
In recent news, a woman from the U.S. has been awarded £85 million after blaming her ovarian cancer on the prolonged use of Johnson & Johnson’s popular talcum powder. 62 year old Lois Slemp reportedly used the product for over 40 years every day, and she is now undergoing chemotherapy after she was diagnosed with ovarian cancer in 2012, which later spread to her liver.
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Philips Respironics V60 ventilator medical devices recalled
The Medicines and Healthcare products Regulatory Agency (MHRA) recently initiated a medical device alert as a result of Philips Respironics’ faulty software that could lead to a sporadic shutdown of the medical device.
The Respironics V60 ventilator’s are used in hospitals to assist in patient ventilation. Recently the medical manufacturer issued a Field Safety Notice (FSN) to notify users of the risk.
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MHRA publishes a class 2 Medicines recall for Sodium Cromoglicate eye drops
The Medicines and Health products Regulation Agency (MHRA) published a medical drug alert on the 18th May 2017 issuing a precautionary recall for bottles of eye drops amidst concerns that the solution can solidify in its container.
Sodium Cromoglicate solution eye drops are typically used to treat red, watery and itchy eyes. Common users are allergy suffers who react adversely to animal hairs, dust or pollen. Marketed as anti-inflammatory, it’s a remedy to alleviate itching and prevent damage to the eyes and delicate surrounding skin by rubbing. The eye drops are also used by contact lens wearers too.
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Issues with battery life of the Accu-Chek Insight insulin pumps
All Accu-Chek Insight insulin pumps have received new instructions for better device management due to previous complaints about the battery lifetime and the device having unexpected shutdowns.
The first warning for the medical device was issued on the 4th August 2015 where Roche Diabetes Care, the medical manufacturers of the insulin pump, issued advice about the correct battery specifications and appropriate pump settings.
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