BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADT OXY. MASK W/TUBING

    MDR report key: 35083 · Received July 25, 1996

    Report

    Report Number
    1417592-1996-05451
    Event Type
    Malfunction
    Date Received
    July 25, 1996
    Report Date
    July 25, 1996
    Manufacturer
    B&F MEDICAL
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TWO PTS WERE IN RECOVERY WHEN NURSE NOTICED THE TUBING COMING OFF THE MASK. NURSE INCREASED THE OXYGEN. BOTH PTS WERE FINE. NO OTHER MEDCIAL TREATMENT REQUIRED.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 ADT OXY. MASK W/TUBING ADULT OXYGENMASK W/TUBING BYG B&F MEDICAL 010608

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other