BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 6231341 · Received January 6, 2017

    Report

    Report Number
    3015876-2017-00026
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 6, 2017
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE.  IT WAS OBSERVED THAT THERE WAS A LOOSE KEPS NUT ON THE INTERNAL WIRE WHICH LEADS TO THE BATTERY CONNECTOR PIN IN THE BATTERY BAY FOR BATTERY #1.  AFTER REPLACEMENT OF THE KEPS NUT, THE DEVICE WILL BE RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT WHERE THE PATIENT WAS ONLY BEING MONITORED, THEIR DEVICE LOST POWER SEVERAL TIMES.  AS A RESULT OF THE LOSS OF POWER EVENTS, THE END USER SWAPPED THE DEVICE OUT FOR A BACKUP DEVICE AND COMPLETED THE EVENT.  THE PATIENT DID NOT SUFFER ANY ADVERSE OUTCOME DURING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10940 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR