BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 11 DEFIBRILLATOR/PACEMAKER

    MDR report key: 154653 · Received March 6, 1998

    Report

    Report Number
    3015876-1998-00105
    Event Type
    Malfunction
    Date Received
    March 6, 1998
    Report Date
    March 6, 1998
    Manufacturer
    PHYSIO-CONTROL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN AN EVALUATION OF THE DEVICE BY THE LOCAL PHYSIO-CONTROL SERVICE REPRESENTATIVE, A COMPLETE FUNCTIONAL TEST WAS PERFORMED AND PROPER OPERATION WAS OBSERVED. TSU'S 213, 214, & 216 WERE PERFORMED AND A BLACK FORMED CARRYING CASE WAS PROVIDED AS A PREVENTATIVE MEASURE AND TO HELP MAINTAIN CUSTOMER CONFIDENCE IN THE DEVICE. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUMBIT ADDITIONAL INFORMATION ON THIS EVENT TO FDA.

    Description of Event or Problem · 1

    PARAMEDICS RESPONDED TO A PERSON, CONDITION UNK. ACCORDING TO THE RPTR, THE DEVICE WOULD NOT PACE THE PT. THE PT WAS NOT RESUSCITATED. THE RPTR INDICATED THE REPORTED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PT. THE RPTR BASED THEIR OPINION ON THE ATTENDING PARAMEDIC'S ASSESSMENT OF THE PT'S VIABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 11 DEFIBRILLATOR/PACEMAKER EXTERNAL DC DEFIBRILLATOR/TRANSCUTANEOUS LDD PHYSIO-CONTROL CORP. 11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN LIFEPAK 11 DIAGNOSTIC CARDIAC MONITOR, P/N D80530.