BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTILARM

    MDR report key: 1943 · Received December 3, 1992

    Report

    Report Number
    1943
    Event Type
    Death
    Date Received
    December 3, 1992
    Date of Event
    November 5, 1992
    Report Date
    November 25, 1992
    Manufacturer
    VENTRONICS
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS FOUND DISCONNECTED FROM A MECHANICAL LIFE SUPPORT VENTILATOR. THE ATTACHED VENTRONICS VENTILARM DEVICE WAS NOT SOUNDING THOUGH IN ON POSITION. THE PATIENT HAD EXPIRED. THE VENTRONICS VENTILARM AND MONAGHAN VENTILATOR 225 WERE IMMEDIATELY SEQUESTERED FOR THIRD PARTY EVALUATION. PRRELIMINARY RESULTS WERE AVAILABLE TO THE HOSPITAL ON NOVEMBER 11, 1992 WHICH SUGGESTED MECHANICAL FAILURE OF THE VENTRONICS VENTILARM. FINAL RESULTS ARE PENDINGDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE 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: USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILARM N/A CBK VENTRONICS 5522 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death