BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2923370 · Received January 22, 2013

    Report

    Report Number
    3015876-2013-00058
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND OBSERVED THAT THE DEVICE WOULD POWER ON AND PROVIDE DEFIBRILLATION THERAPY. FURTHER EXAMINATION, HOWEVER, SHOWED THAT THREE BATTERY PINS WERE LOOSE, WHICH COULD POTENTIALLY CAUSE THE DEVICE TO SHUT DOWN DURING OPERATION. HE THEN TIGHTENED THE BATTERY PINS AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. THE LIKELY CAUSE OF THE REPORTED ISSUE WAS LOOSE BATTERY PINS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT ABOUT SIX MINUTES INTO MONITORING A PATIENT THEIR DEVICE POWERED OFF BY ITSELF. THE END USER POWERED THE UNIT BACK ON AND IT REMAINED ON FOR ANOTHER 5-6 MINUTES BEFORE POWERING OFF A SECOND TIME. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31438 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1