BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPERATURE PROBE

    MDR report key: 10028 · Received March 8, 1994

    Report

    Report Number
    10028
    Event Type
    Malfunction
    Date Received
    March 8, 1994
    Report Date
    December 21, 1993
    Manufacturer
    ELECTROMEDICS, INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TEMP. DID NOT READ OUT ON DIGITAL AND ALARM KEPT ALARMING 0 RADIANT WARMER INVESTIGATED IS FUNCTIONING. PROBLEM DISCOVERED IMMEDIATELY, NO PATIENT INVOLVEMENT. PRODUCT PROBLEM REPORTED TO USP AND FDA.INVALID 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 TEMPERATURE PROBE FLL ELECTROMEDICS, INC. M688650

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other