BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTON ANESTHESIA DELIVERY UNIT

    MDR report key: 13236873 · Received January 11, 2022

    Report

    Report Number
    MW5106591
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    September 27, 2021
    Report Date
    January 7, 2022
    Manufacturer
    PENTON LTD.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UPON INTUBATION IN MAIN OPERATING ROOM, THE ANESTHESIA GAS MACHINE HAD A MALFUNCTION. THE BELLOWS WOULD NOT RISE ALL THE WAY, SUGGESTING A LEAK. THE MACHINE WAS CHANGED AND THERE WAS NO ADVERSE PATIENT OUTCOME. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331524 PENTON ANESTHESIA DELIVERY UNIT GAS-MACHINE, ANESTHESIA BSZ PENTON LTD. PRIMA 460

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other