BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 6065933 · Received October 30, 2016

    Report

    Report Number
    3015876-2016-01299
    Event Type
    Malfunction
    Date Received
    October 30, 2016
    Date of Event
    October 5, 2016
    Report Date
    July 21, 2017
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K122600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

     THE CUSTOMER DECLINED TO RETURN THE DEVICE TO PHYSIO-CONTROL FOR EVALUATION. THEY CONFIRMED THAT THE DEFIBRILLATION ELECTRODES THAT WERE USED DURING THE EVENT, HAD BEEN EXPIRED.  AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, A CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED ISSUE 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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHYSIO-CONTROL THAT THE CUSTOMER'S DEVICE DID NOT RECOGNIZE THE ELECTRODES WHEN THEY WERE CONNECTED TO THE DEVICE. NO INFORMATION WAS PROVIDED IF THERE WAS PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION AND CONFIRMED THAT THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717030 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1