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Medical Device Power Cords Safety Investigation - Initial Communication
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document.write("FDA MedWatch Safety Alert FDA is investigating whether certain types of power cords used with medical devices may be defective. Two medical device manufacturers (Hospira, Inc. and Abbott Nutrition) have sent FDA 122 reports of sparking, charring, and fires from the power cords used with their...
Safety Investigation of CT Brain Perfusion Scans - Initial Communication
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document.write("FDA MedWatch Safety Alert FDA has become aware of radiation overexposures during perfusion CT imaging to aid in the diagnosis and treatment of stroke. Over an 18-month period, 206 patients at a particular facility received radiation doses that were approximately eight times the expected level. In...
Unomedical Manual Pulmonary Resuscitator - Recall
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document.write("FDA MedWatch Safety Alert Unomedical and FDA notified healthcare professionals about the recall of the single-patient use Manual Pulmonary Resuscitator because of a malfunction which may impair the ability of the device to generate the positive pressure necessary to function properly and could...
Philips Heartstart Fr2+ Automated External Defibrillators - Recall
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document.write("FDA MedWatch Safety Alert Philips and FDA notified healthcare professionals of the recall of 5,400 HeartStart FR2+ automated external defibrillators (AED) due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. The AEDs...
Penumbra Neuron 6F 070 Delivery Catheter - Class I Recall
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document.write("FDA MedWatch Safety Alert Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter...
Errors in Radiation Therapy
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document.write("Pennsylvania Patient Safety Authority Radiation therapy is a highly regulated medical practice with historically low error and injury rates. Rare instances of radiation therapy errors resulting in severe injuries have been documented. These errors can result in devastating and sometimes fatal...
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Focuses on promoting awareness of medical devices in hospital laboratories and reporting identified problems to FDA?s Office of In Vitro Diagnostics. To see recently submitted MedSun Laboratory Device Reports, see Laboratory/In Vitro Diagnostic Devices.Sodium Azide Safety Tip (OIVD)
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document.write("FDA MedWatch Safety Alert FDA has received an increasing number of reports of explosions involving solutions containing sodium azide used in clinical facilities. This communication is to remind laboratories and hospitals about the danger posed by long-term accumulation of sodium azide solutions,...
Higher Standards on the Way for Glucose Meters?
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document.write("AACC Clinical Laboratory News The FDA will consider tightening standards for strip-based blood glucose meters, echoing the concerns of many in the clinical lab field who have warned for a decade that the meters are not reliable. FDA also acknowledged an issue that has been a growing concern among...
Lab Safety: Evaluating Training
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document.write("Lab Manager Magazine With a research facility's typical mix of research laboratories, instrument rooms, chemical storage, waste handling and busy receiving/loading docks, a wide array of hazards is always present. Every day, employees must deal with these hazards while hopefully avoiding...
Highlighted Reports
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document.write("This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of...
Summary of MedSun Reports Describing Adverse Events With Breast Tissue Expanders
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document.write("A tissue expander is a device intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. It is made of an inflatable silicone elastomer shell filled with Normal...