BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADULT STAR MODEL 1202000

    MDR report key: 254882 · Received December 15, 1999

    Report

    Report Number
    MW1017730
    Event Type
    Injury
    Date Received
    December 15, 1999
    Date of Event
    November 30, 1999
    Report Date
    December 13, 1999
    Manufacturer
    NELLCOR-PURITAN BENNETT, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT POST OP IN ICU ON VENTILATOR. ON 11/30 AT APPROX 13:30 THE VENTILATOR ALARMED "VENT INOP" AND POWERED OFF. ICU AND CARDIOPULMONARY PERSONNEL RESPONDED IMMEDIATELY WITH MANUAL VENTILATION AND EXCHANGED VENTILATOR. PT TOLERATED THE EVENT WITH NO INJURIES. BIOMED EVALUATED VENTILATOR AND RECORDED THE FOLLOWING ALARM HISTORY. 5 IDENTICAL ALARMS WERE RECORDED: "E94 11/30/99 01:37 PM, MPU EXHALATION FLOW TRANSDUCER ZERO EXCEEDS +/- 75 LPM-CHECK ZERO." ALARM ALSO OCCURRED AT 1:41, 1:43, 1:44 AND 1:46. CONTACTED NELLCOR-PURITAN BENNETT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT STAR MODEL 1202000 ADULT VENTILATOR CBK NELLCOR-PURITAN BENNETT, INC. 1202000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Life Threatening