BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSITIVE PRESSURE VENTILATOR

    MDR report key: 8184 · Received August 11, 1993

    Report

    Report Number
    8184
    Event Type
    Injury
    Date Received
    August 11, 1993
    Date of Event
    June 1, 1993
    Report Date
    June 4, 1993
    Manufacturer
    PURITAN BENNETT
    Product Code
    BYT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    VENTILATOR WAS "BLACKED OUT", NOT OPERATING AND READY"ERROR 1501" WITH NO ALARMS. PATIENT MAY HAVE BEEN COMPROMISED. SERVICE REPRESENTATIVE HAS BEEN CALLED IN AND IS DOING A DIAGNOSTIC EVALUATION.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-APR-93. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. 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. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. 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 POSITIVE PRESSURE VENTILATOR BYT PURITAN BENNETT PB7200A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention