BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPUR II PEDI. BAG RESVR

    MDR report key: 11841498 · Received May 18, 2021

    Report

    Report Number
    9610691-2021-00009
    Event Type
    Death
    Date Received
    May 18, 2021
    Report Date
    May 18, 2021
    Manufacturer
    AMBU A/S
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE FOR THE LEAKING MANOMETER WAS RETURNED TO OUR MANUFACTURING FACILITY FOR INVESTIGATION ON MAY 07, 2021. THE SAMPLE WAS IMMEDIATELY EVALUATED BY THE QA ENGINEER. THE FOLLOWING FUNCTIONAL TESTS WERE COMPLETED ON THE RETURNED SAMPLE: HIGH/LOW PRESSURE TEST; VOLUME TEST; 02 CONCENTRATION TEST RECOIL TIME TEST. EACH OF THE ABOVE TESTS THAT WE PERFORMED IDENTIFIED NO FAILURES WITH THE RETURNED SAMPLE. THE RESULTS OF ALL TESTS WERE WITHIN THE PRODUCT SPECIFICATIONS. AS DESCRIBED IN THE IFU, IT IS IMPORTANT TO INSPECT THE RESUSCITATOR AND PERFORM A BRIEF FUNCTIONAL TEST PRIOR TO USE AND TO NOT USE THE PRODUCT IF A TEST FOR FUNCTIONALITY FAILS.

    Description of Event or Problem · 1

    PER CUSTOMER PATIENT WAS QUICKLY MOVED TO PICU (PEDIATRIC INTENSIVE CARE UNIT) AND WAS IN PROCESS OF DECOMPENSATING. HIS HGB WAS ONLY A BIT OVER 2 SO DID NOT HAVE ANY RESERVE. SPUR II RESUSCITATOR WAS LEAKING AROUND MANOMETER PORT WHICH AFFECTED THE PATIENT AND THE PATIENT WAS DECOMPENSATING. BACK UP RESUSCITATOR WAS NOT AVAILABLE. INFORMATION WAS PROVIDED ON (B)(6) 2021 THAT PATIENT EXPIRED, CUSTOMER MENTIONED THAT THE RESUSCITATOR WAS NOT THE CAUSE OF THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737116 SPUR II PEDI. BAG RESVR AMBU SPUR II BTM AMBU A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 Death