BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLTER MONITOR

    MDR report key: 5835 · Received July 1, 1993

    Report

    Report Number
    5835
    Event Type
    Malfunction
    Date Received
    July 1, 1993
    Date of Event
    March 8, 1993
    Report Date
    March 26, 1993
    Manufacturer
    APPLIED CARDIAC SYSTEMS, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    HOLTER MONITOR WAS NOTED BY STAFF TO MALFUNCTION ON SUBSEQUENT PATIENT, AFTER RETURNED BY PREVIOUS PATIENT. THERE WAS NO APPARENT ADVERSE EFFECT ON EITHER PATIENT. SENT TO CLINICAL ENGINEERING AND THE MANUFACTURER WAS NOTIFIEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-NOV-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: MECHANICAL PROBLEM, TELEMETRY EQUIPMENT. CONCLUSION: DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLTER MONITOR DRT APPLIED CARDIAC SYSTEMS, INC. 8500 2194

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other