BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3893652 · Received June 25, 2014

    Report

    Report Number
    3015876-2014-00704
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Removal / Correction Number
    3015876-05/01/2014-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES: THE CUSTOMER INDICATED THEY WOULD OBTAIN A REPLACEMENT BATTERY. THE DEVICE OR BATTERY HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CUSTOMER HAS BEEN PROVIDED WITH DETAILED INSTRUCTIONS ON HOW TO VERIFY THE READINESS OF THEIR DEVICE AND DETERMINING THE BATTERY¿S CHARGE STATUS. THE CUSTOMER HAS ALSO BEEN REMINDED OF THE IMPORTANCE OF ALWAYS CARRYING A SPARE FULLY-CHARGED BATTERY. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: THE CUSTOMER INDICATED THEY WOULD OBTAIN A REPLACEMENT BATTERY. THE BATTERY WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE BATTERY WAS APPROXIMATELY 8 YEARS OLD AND HAD LIKELY BECOME DEPLETED NORMALLY DUE TO AGE AND USE. THE CUSTOMER HAS BEEN PROVIDED WITH DETAILED INSTRUCTIONS ON HOW TO VERIFY THE READINESS OF THEIR DEVICE AND DETERMINING THE BATTERY¿S CHARGE STATUS. THE CUSTOMER HAS ALSO BEEN REMINDED OF THE IMPORTANCE OF ALWAYS CARRYING A SPARE FULLY-CHARGED BATTERY.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THEY WOULD OBTAIN A REPLACEMENT BATTERY. THE DEVICE OR BATTERY HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CUSTOMER HAS BEEN PROVIDED WITH DETAILED INSTRUCTIONS ON HOW TO VERIFY THE READINESS OF THEIR DEVICE AND DETERMINING THE BATTERY¿S CHARGE STATUS. THE CUSTOMER HAS ALSO BEEN REMINDED OF THE IMPORTANCE OF ALWAYS CARRYING A SPARE FULLY-CHARGED BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY CHECKED THE CHARGE LEVEL OF THEIR DEVICE BATTERY AND FOUND THAT THE DEVICE BATTERY WAS AT A VERY LOW STATE OF CHARGE WHICH MAY NOT BE SUFFICIENT FOR PATIENT USE. THE CUSTOMER WAS NOTIFIED OF A VOLUNTARY FIELD CORRECTIVE ACTION (CORRECTIONS AND REMOVALS NUMBER 3015876-05/01/2014-001C) FOR THEIR DEVICE . A CUSTOMER NOTIFICATION LETTER WAS SENT TO THEM. THERE WAS NO PATIENT USE ASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369990 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1