BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAMSCOPE

    MDR report key: 8104 · Received March 16, 1994

    Report

    Report Number
    8104
    Event Type
    Malfunction
    Date Received
    March 16, 1994
    Date of Event
    March 10, 1994
    Report Date
    March 14, 1994
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING A SHORT POWER OUTAGE, ALL THE CARDIAC MONITORS SHUT DOWN. WHEN POWER WAS RESTORED, APPROX 30% OF THE DEVICES DID NOT POWER UP TO FULL CAPABILITY. DEFINE FULL CAPABILITY: NO WAVE FORMS OR DIGITAL NUMERICS APPEARED ON THE SCREEN. THE STAFF HAD TO TURN OFF ALL UNITS AND TURN BACK ON TO REGAIN FULL CAPABILITY.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: .DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-94. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. 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: MAYBE. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAMSCOPE CARDIAC MONITOR DRT MARQUETTE ELECTRONICS, INC. SCOPE 12C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other