BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS

    MDR report key: 847219 · Received April 24, 2007

    Report

    Report Number
    847219
    Event Type
    Malfunction
    Date Received
    April 24, 2007
    Date of Event
    April 1, 2007
    Report Date
    April 24, 2007
    Manufacturer
    DIVERSIFIED MEDICAL NCE
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    DIVERSIFIED MEDICAL NCE SELLS REPLACEMENT BATTERIES THAT ARE MANUFACTURED FOR A SPECIFIC MAKE AND MODEL MEDICAL DEVICE. THE REPLACEMENT BATTERY FROM DIVERSIFIED/NCE FOR USE IN A DIFFERENT MANUFACTURER'S VITAL SIGNS MONITOR SEEMS TO BE INCOMPATIBLE WITH THE MONITOR'S CHARGING SYSTEM. NEARLY 10% OF THE REPLACEMENT BATTERIES PURCHASED FROM DIVERSIFIED AND INSTALLED BY THIS HOSPITAL HAVE SWELLED/CRACKED CASES AND LEAK. ONE MONITOR HAD A DAMAGED BATTERY COMPARTMENT WITH DETERIORATED BATTERY TERMINALS. THERE WERE NO PATIENT RELATED INCIDENTS AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS BATTERY MOQ DIVERSIFIED MEDICAL NCE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *