BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMV VENTILATOR

    MDR report key: 1262 · Received September 2, 1992

    Report

    Report Number
    1262
    Event Type
    Injury
    Date Received
    September 2, 1992
    Date of Event
    August 3, 1992
    Report Date
    August 12, 1992
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING CT SCAN, THE PATIENT BECAME DISCONNECTED FROM VENTILATOR. VENTILATOR DOES NOT HAVE BUILT IN ALARM SYSTEM. PATIENT FOUND APNEIC AND IN ASYSTOLE. RESUSCITATIVE MEASURES INITIATED AND SUCCESSFUL. EXTERNAL ALARM INSTALLEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: STORAGE/SHIPMENT, UNANTICIPATED LONG TERM COMPLICATION OF PROCEDURE, OTHER. CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMV VENTILATOR N/A CBK MONAGHAN MEDICAL CORP. 225 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention