BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1883873 · Received October 22, 2010

    Report

    Report Number
    3015876-2010-01168
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE WITH AN OLDER BATTERY AND A LOW BATTERY INDICATION. THE DEVICE PROMPTED "LOW BATTERY" AND THEN POWERED OFF; HOWEVER, WITH A NEW BATTERY AND A LOW INDICATION, THE DEVICE PASSED A PERFORMANCE INSPECTION PROCEDURE (PIP) WITH THE DEVICE PROMPTING "LOW BATTERY", BUT THE DEVICE NEVER POWERED OFF. PHYSIO-CONTROL RECOMMENDED THE CUSTOMER TO STOP USING THEIR OLDER BATTERIES AND REPLACE THEM WITH NEW ONES. NO FAILURE OF THE DEVICE COULD BE FOUND. AFTER PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED; HOWEVER, WAS LIKELY TO BE DUE TO THE CUSTOMER'S USE OF OLD BATTERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE POWERED OFF DURING PT USE. THERE WAS NO ADVERSE EVENT OR COMPROMISE TO PT CARE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK