BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER

    MDR report key: 4595 · Received February 25, 1993

    Report

    Report Number
    4595
    Event Type
    Malfunction
    Date Received
    February 25, 1993
    Date of Event
    December 21, 1992
    Manufacturer
    VIGGO SPECTROMED
    Product Code
    BXO
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TRANSDUCER FAILURE STRAIGHT OUT OF PACK BEFORE USE - GOLD TO GOLD TAB FAILUREDEVICE LABELED FOR SINGLE USE. 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: END OF LIFE - PREMATURE, MECHANICAL PROBLEM. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSDUCER BXO VIGGO SPECTROMED 92AUG004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other