Seven serious medical device failures1. Allergan breast implants2. Medtronic insulin pumps3. Edwards Lifesciences monitoring platforms4.
Nov 30, 201615 votes, 16 comments. I have an assignment for my intro class where I must research a biomedical engineering disaster.
In engineering terms, failure generally means that a device or structure has ceased to perform its intended function. Saying a part has failed does not provide AbstractFailure Analysis Investigation FatigueOrthopaedic Implant Failure
Medical device failures, like those of any engineered structure, generally fall into one of three categories: Improper design. Manufacturing defect. Misapplication/abuse.
Are biofabricated and OOC disease modeling platforms still a challenge?
Overall, biofabricated and OOC disease modeling platforms are still facing some challenges with their integration into clinical applications.
From the biomimicry perspective, embodying immune and endocrine responses in such platforms is still a significantly complex and daunting task.
Edwards Lifesciences Monitoring Platforms
American medtech company Edwards Lifesciencesdevelops several clinical platform devices used to monitor patient blood pressure and pulse during, and after surgery.
In March 2019, the firm informed users of an issue affecting 11,000 of these devices in the US after reports that fluids leaking into its AC power outlet could result in an electrical sh.
Flow-I Anesthesia Systems
The FLOW-i anaesthesia delivery system administers anaesthetic while also providing ventilation to patients with little or no ability to breathe — from newborns to morbidly obese adults.
In April 2015 Maquet— the Swedish healthcare company that manufactures the device — was forced to recall 69 of these systems in the US after receiving 10 foreign r.
Medtronic Insulin Pumps
Medtronic’s MiniMed insulin pump is used by people with diabetes to self-administer insulin in order to manage the condition.
In August 2018, the US medical device company was forced to issue a recall of more than 1,000 of these devices due to a potential cyber security riskin which hackers could gain control of the pump’s remote control.
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Physio-Control Defibrillators
Physio-Control’s LIFEPAK 15 heart monitor and defibrillator is used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, and restart their heart’s normal rhythm.
The American portable defibrillation company was forced to issue a recall for 139 copies of the device in January 2017.
This came after it was discovered that elec.
What causes medical device failures?
Inadequate instructions, component issues, and assembly errors--those are but some of the causes behind recent medical device recalls and serious warnings announced by the FDA.
Here are some of the major medical device failure events since January:
1.
Inadequate Sterilization for an Orthopedic Surgery Tool . Why do medical devices harm people's wellbeing?
Medical device failures and malfunctions invariably harm people’s wellbeing due to the fact they are often deployed on the frontline of patient care and in users’ homes.
Will biomedical research continue to grow?
In the last decades, biomedical research has significantly boomed in the academia and industrial sectors, and it is expected to continue to grow at a rapid pace in the future.
An in-depth analysis of such growth is not trivial, given the intrinsic multidisciplinary nature of biomedical research.
Zimmer Biomet Spinal Fusion Stimulators
In April 2017 Zimmer Biomet had to recall 33 implantable spinal fusion stimulators — a device inserted into a patient’s back during spinal fusion surgery to increase the possibility of permanently connecting two or more bones.
During its “routine monitoring procedure”, the US company found that two different spinal fusion products contained high le.
