The July 2013 MedSun Newsletter

Recalls and Safety Alerts:

Medtronic SynchroMed Implantable Infusion System Devices: Class I Recall

Patients and caregivers should contact their physicians immediately if they hear a device alarm or experience symptoms of a drug overdose or underdose…

 Medtronic Xomed NIM Trivantage EMG Endotracheal Tube: Class I RecallThe firm received complaints of "cuff leak" or "cuff deflation" occurring when the inflation valve cap is inappropriately removed (pulled off, instead of snapped-off sideways)...

 Respironics California, Inc V60 Ventilators - Class I RecallRecall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly…

 Endologix, Inc. AFX Introducer System: Class I RecallAFX Introducer System Model S17-45 recall due to reports of the dilator breaking during procedures…

 Cybersecurity for Medical Devices and Hospital Networks: FDA Safety CommunicationFDA is recommending that medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack…

Symbios GOPump and GOBlock Kits: Class I RecallThe affected products may have excessively high flow rates which may cause patient toxicity due to the rapid influx of medication...

Workshops:

Public Workshop: Battery-Powered Medical Devices Workshop – Challenges and Opportunities, July 30-31, 2013This meeting is a way to better understand and address the potential challenges related to the design/development, selection, purchase, use, and maintenance of battery-powered medical devices…