BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NPB

    MDR report key: 364510 · Received December 7, 2001

    Report

    Report Number
    8020893-2001-00014
    Event Type
    Malfunction
    Date Received
    December 7, 2001
    Date of Event
    September 7, 2001
    Report Date
    December 7, 2001
    Manufacturer
    NELLCOR PURITAN BENNETT IRE
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2001 TYCO HEALTHCARE RECEIVED A VOLUNTARY MEDWATCH IN RELATION TO AN 840 VENTILATOR SYSTEM. THE MEDWATCH REPORT ALLEGED THAT THE VENTILATOR QUIT CYCLING DURING PT USE. THE REPORT INDICATED THAT THE VENTILATOR ALARMED "VENT INOPERATIVE" AND "SAFETY VALVE OPEN". THERE WAS NO REPORT OF PT HARM. ADD'L INFO RECEIVED FROM THE CUSTOMER INDICATES THAT THE NURSE, WHO WAS AT THE BEDSIDE, BEGAN TO MANUALLY VENTILATE RIGHT AWAY WITH "AMBU BAG" AND OXYGEN. SHE NOTES THAT THE PT "WENT INTO ASYSTOLE", BUT RECOVERED IMMEDIATELY WHEN MANUALLY VENTILATED WITH OXYGEN. SHE DID NOT STATE THAT THERE WAS ANY UNPLANNED ADD'L TREATMENT GIVEN TO THE PT. THE CUSTOMER STATED THAT AT A LATER TIME AFTER FAMILY REQUESTED A "DO NOT RESUSCITATE" STATUS DUE TO THE PT'S CONDITION AND PROGNOSIS. THE PT LATER EXPIRED AS A RESULT OF THE PT'S DISEASE AND NOT RELATED TO ANY DEVICE ISSUE OR ALLEGED/REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55262 NPB VENTILATOR CBK NELLCOR PURITAN BENNETT IRE 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention