MedSun Update

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Title: MedSun Update

 

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Highlighted articles include:

 

Medtronic Octopus Nuvo Tissue Stabilizer: Class I Recall

There is the potential that a component of this device could fracture during use…

 

Huber Needles: Recall - Risk of Coring

FDA notified healthcare professionals of the Class I Recall of certain Huber needles that…

 

Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility

Routine internal testing conducted on this product found that some of these syringes may leak and lose sterility...

 

CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy

Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may…

 

New Technology and Health Care Costs - The Case of Robot-Assisted Surgery

Technological innovation in health care is an important driver of cost growth. Doctors and patients often embrace new modes of treatment…  

 

Compressed Gas Cylinder Safety

What follows here is a condensed set of basic guidelines applicable to all gas cylinders. Taking the time to develop and implement a compressed gas safety program…

 

Guidant Vitality HE Implantable Cardioverter Defibrillator: Class II Recall & Guidant, Contak Renewal CRT: Class II Recall

Exposure to a magnet may cause a magnetic reed switch to become…

 

Philips IntelliVue MP2 patient monitor recall: Class II Recall

Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing…

 

Featured HomeNet Report of Interest

In this featured HomeNet report of interest, an infusion pump was connected to a home care patient with the intent to deliver…  

 

Resectoscopes for Infants and Babies: Medical Device Safety Tips

This safety tip originally appeared in October's MedSun newsletter but the KidNet team would like to reiterate its importance for pediatric patient populations…

 

MedSun in Action

Small Sample Surveys are one of many tools the Food and Drug Administration (FDA), Center for Devices and Radiological Health, MedSun Project uses to evaluate the public health impact of the potential problems associated with the use of medical devices.  November 2010’s Newsletter includes summaries of seven small sample surveys that were conducted with MedSun facilities during 2009 and during the first few months of 2010…

 

Highlighted Reports

This section contains a sample of reports from all the MedSun reports received during a particular period…

 

Summary of MedSun Reports Describing Adverse Events With Thermal Regulating Systems

Per the code of federal regulations, "A thermal regulating system is…

 

 

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