BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMBU SPUR II ADULT TUBE RES., M MASK

    MDR report key: 19810671 · Received July 23, 2024

    Report

    Report Number
    1220828-2024-00014
    Event Type
    Death
    Date Received
    July 23, 2024
    Date of Event
    May 25, 2024
    Report Date
    July 23, 2024
    Manufacturer
    AMBU INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FAILURE OF COMPRESSIBLE BAG NOT RE-INFLATING AND HAVING A CRACK OR SEPARATION, COULD NOT BE VERIFIED AS NO SAMPLE OR PHOTO WAS RETURNED FOR INVESTIGATION. REVIEW OF PRODUCTION RECORDS DID NOT REVEAL ANY ABNORMALITY. POSSIBLE CAUSES FOR COMPRESSIBLE BAG NOT RE-INFLATING ARE A DEFORMATION OF THE COMPRESSIBLE BAG OR A MALFUNCTION OF INLET VALVE DISC. POSSIBLE CAUSES FOR A CRACK OR SEPARATION ARE A DAMAGE BY A SHARP OBJECT DURING USE OR A DETACHMENT OF INLET VALVE OR PATIENT VALVE HOUSING FROM THE COMPRESSIBLE BAG. THERE ARE 100% FUNCTION TESTS PERFORMED AFTER MANUFACTURING, INCLUDING A VERIFICATION OF RE-EXPANSION TO THE DEFAULT STATE AFTER COMPRESSION OF SPUR II. COMPRESSIBLE BAG CRACK OR INABILITY TO REINFLATE WOULD BE DETECTED DURING VISUAL INSPECTION AS A PART OF FINAL QUALITY CONTROL PROCEDURE. SPUR II IS PACKED MANUALLY ACCORDING TO PACKING PROCEDURE. THUS, THE PRODUCT SHOULD BE WITHIN SPECIFICATIONS PRIOR TO DELIVERY TO CUSTOMER. DUE TO THE LIMITED INFORMATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. AS STATED IN THE INSTRUCTIONS FOR USE (LBL-005931 REV.15) "ALWAYS INSPECT THE RESUSCITATOR AND ACCESSORIES (E.G. FACE MASK, PEEP VALVE, FILTERS, ETC.) AND PERFORM A FUNCTIONAL TEST AFTER UNPACKING, CLEANING, ASSEMBLY AND PRIOR TO USE. WE WILL KEEP MONITORING SIMILAR INCIDENTS.

    Description of Event or Problem · 0

    DURING THE COURSE OF CARDIAC ARREST RESUSCITATION, THE BAG PORTION OF THE BAG VALVE MASK ASSEMBLY FAILED TO RE-INFLATE. UPON ARRIVAL AT THE HOSPITAL, A MEMBER OF THE EMERGENCY DEPARTMENT STAFF LOCATED A SEPARATION IN OR CRACK IN THE RUBBER BAG. PATIENT WAS PRONOUNCED DECEASED AFTER ARRIVING AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472192 AMBU SPUR II ADULT TUBE RES., M MASK AMBU SPUR II ADULT TUBE RES., M MASK BTM AMBU INC. 521000001 1000919409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death