BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9 DEFIBRILLATOR/MONITOR

    MDR report key: 1399736 · Received April 13, 2009

    Report

    Report Number
    3015876-2009-00477
    Event Type
    Malfunction
    Date Received
    April 13, 2009
    Date of Event
    March 16, 2009
    Report Date
    March 16, 2009
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K881153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE RETURNED DEVICE AND OBSERVED THAT THE SMARTWATCH RAM W/COIN CELL BATTERY, DESIGNATOR U28, USED FOR DATE, TIME, CALIBRATION CONSTANTS, ETC., HAD BEEN REPLACED WITH A SMARTWATCH RAM W/COIN CELL BATTERY THAT IS NOT COMPATIBLE WITH THE DEVICE. PHYSIO REMOVED AND REPLACED U28 AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    FOUND DURING ROUTINE TESTING. THE CUSTOMER CALLED TO REPORT THE DEVICE'S SERVICE INDICATOR WAS ON AND HE WAS UNABLE TO CALIBRATE THE DEVICE. THE DEVICE WAS RETURNED TO PHYSIO-CONTROL, REDMOND FOR EVALUATION. WHEN THE DEVICE WAS EVALUATED, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WOULD NOT OPERATE. THERE WAS NO PT ASSOCIATED WITH THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 9 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA