BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1000672 · Received February 19, 2008

    Report

    Report Number
    3015876-2008-00073
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Report Date
    January 15, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K890079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED AN OFFER OF SVC FROM PHYSIO-CONTROL AND PURCHASED A REPLACEMENT DEFIBRILLATION CABLE FOR THE DEVICE. THE CUSTOMER RETURNED THE DEFIBRILLATION CABLE TO PHYSIO-CONTROL, BUT IT WAS INADVERTENTLY SCRAPPED AND IS NOT AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    THE RPTR CONTACTED PHYSIO-CONTROL TO INQUIRE ABOUT REPLACING THE DEVICE'S DEFIBRILLATION CABLE. ACCORDING TO THE RPTR, THE CABLE HAS THREE "HOLES" AND THE DEFIBRILLATOR HAD ARCED TO A PT'S SHEET'S DURING A CODE. THE RPTR STATED THAT THE PT WAS "OK" AND INDICATED THAT THERE WERE NO ADVERSE AFFECTS TO THE PT AS A RESULT OF THE DEVICE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC. 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA