BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL NTP

    MDR report key: 491 · Received April 2, 1992

    Report

    Report Number
    491
    Event Type
    Death
    Date Received
    April 2, 1992
    Report Date
    March 27, 1992
    Manufacturer
    ZMI CORPORATION
    Product Code
    DRK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A HEWLETT & PACKARD DEFIBRILLATOR MONITOR WAS ALSO IN USE AT THE TIME OF THE CODE. THE MODEL NUMBER IS 43110. THIS DEVICE IS FULLY FUNCTIONALINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL NTP DRK ZMI CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death