BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 2994220 · Received March 8, 2013

    Report

    Report Number
    3015876-2013-00185
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A THIRD PARTY AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE THIRD PARTY AGENT PROVIDED THE CUSTOMER WITH A NEW DEVICE. 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): A THIRD PARTY AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE THIRD PARTY AGENT PROVIDED THE CUSTOMER WITH A NEW DEVICE. 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.(B)(4): THE DEVICE WAS RETURNED TO PHYSIO-CONTROL FAILURE ANALYSIS CENTER FOR FURTHER EVALUATION. PHYSIO-CONTROL DETERMINED THAT INTEGRATED CIRCUIT CHIP, DESIGNATOR U19, LOCATED ON THE DIGITAL PCB ASSEMBLY WAS CAUSING THE DEVICE TO LOG IN AN EVENT CODE AND WAS ALSO CAUSING THE DEVICE TO DISPLAY THE MESSAGE CONNECT ELECTRODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE THE DEVICE DID NOT DETECT THE ELECTRODES. THEREFORE THE DEVICE COULD NOT PROVIDE DEFIBRILLATION. THERE IS NOT PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99076 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1