BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3031891 · Received April 3, 2013

    Report

    Report Number
    3015876-2013-00265
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO PHYSIO-CONTROL FAILURE ANALYSIS CENTER FOR FURTHER EVALUATION. IT WAS OBSERVED THAT THE DEVICE DIGITAL PCB ASSEMBLY WOULD NOT ALLOW A COMPLETE DEVICE BOOT CYCLE. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE. THE CAUSE OF THE DIGITAL PCB ASSEMBLY FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REGULAR CHECK, THE DEVICE DID NOT HAVE ANY DC POWER. A NEW BATTERY WAS INSERTED BUT THE DEVICE DID NOT POWER ON. THEREFORE THE DEVICE COULD NOT PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136108 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1