BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMA 460

    MDR report key: 4924370 · Received July 9, 2015

    Report

    Report Number
    MW5044391
    Event Type
    Other
    Date Received
    July 9, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 9, 2015
    Manufacturer
    PENLON
    Product Code
    BSZ
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS IN THE OPERATING ROOM, INTUBATED, READY FOR PROCEDURE. THE ANESTHESIA MACHINE MALFUNCTIONED AND THE ANESTHESIOLOGIST TOOK APART THE ABSORBER ASSEMBLY AND THEN REASSEMBLED IT IN ORDER TO GET THE MACHINE TO FUNCTION. THERE WAS NO ADVERSE EVENT, BUT THE PT UNDERWENT ADDITIONAL ANESTHESIA TIME. THE VENDOR, (B)(6) WAS CONTACTED AND BIOMED EVALUATED THE MACHINE. THERE WAS A LEAK FOUND AT THE CO2 ABSORBER, PROBABLY DUE TO MIS-SEATED SODASORB CANISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446587 PRIMA 460 ANESTHESIA MACHINE BSZ PENLON 460051406 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other