BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PM THERAPY S

    MDR report key: 4152596 · Received October 6, 2014

    Report

    Report Number
    9615050-2014-05505
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    Z-1170-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND WHILE RUNNING THE CUSTOMER'S LAST PROTOCOL THE DEVICE WOULD POWER DOWN WHEN IT IS KNOCKED ONTO A BENCH WHILE RUNNING ON DC POWER. IT WAS OBSERVED THAT WHEN THE POWER LOSS OCCURS, THE DEVICE WOULD ALARM A CHIRP TONE. THIS WAS TESTED THREE TIMES WITH THE SAME RESULTS. VISUAL INSPECTION FOUND THAT THE BATTERY CONTACT J104 OF THE MIDDLE PWA WAS LOOSE AND THERE WAS EVIDENCE OF CORROSION. THIS MAY CAUSE INTERMITTENT CONTACT BETWEEN THE AA BATTERIES AND THE POSITIVE BATTERY CONTACT WHICH WILL RESULT IN INTERMITTENT POWER LOOSES. A VISUAL INSPECTION ALSO FOUND CORROSION ON THE CASE ASSEMBLY. THE PROBABLE CAUSE OF THE POWER LOSS MAY BE DUE TO A LOOSE BATTERY CONTACT J104 ON THE MIDDLE PWA. THERE WAS ALSO CONTAMINATION ON THE POSITIVE BATTERY CONTACT J104. THE PROBABLE CAUSE WAS DUE TO LEAKAGE FROM THE DISPOSABLE BATTERIES. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, CORROSION DUE TO BATTERY LEAKAGE WAS NOTED IN THE BATTERY COMPARTMENT OF THE DEVICE. FURTHER TESTING FOUND THAT THE DEVICE POWERED OFF BY ITSELF WITHOUT SOUNDING AN AUDIBLE ALARM TONE WHEN IT WAS BUMPED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622200 GEMSTAR PM THERAPY S 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA