BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMBU SPUR II

    MDR report key: 3818217 · Received May 9, 2014

    Report

    Report Number
    9610691-2014-00001
    Event Type
    Death
    Date Received
    May 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    AMBU A/S
    Product Code
    BTM
    PMA / PMN Number
    K042682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WOULD BE RETURNED TO AMBU BUT SPECIFIC LOT INFO PROVIDED FOR TRACEABILITY. THE PRODUCTION RECORDS (ASSEMBLY PROCESS RECORD, REWORK AND SCRAP RECORD, PQC ASSEMBLY PROCESS RECORD AND FINAL PRODUCT INSPECTION RECORD) HAVE BEEN REVIEWED, AND DID NOT FIND ANY ABNORMALITY DURING PRODUCTION. THE FACE MASK IS MANUALLY PACKED INTO THE SPUR II KIT. LACK OF MASK INSIDE THE SPUR II PACKAGING MIGHT BE A RESULT OF HUMAN ERROR OCCURRED DURING PACKING PROCESS OR DURING STORAGE OR HANDLING AT THE USER FACILITY (MASK WAS TAKEN OUT OF PACKAGING). AT WHICH STEP THE MASK WENT MISSING IS NOT IDENTIFIED. SPUR II RESUSCITATOR IS DESIGNED FOR USE BY CPR-TRAINED PARAMEDICS, AND INFO FOR SAFETY PROVIDED IN ACCOMPANYING DOCUMENT (IFU) INFORM THAT THE RESUSCITATOR MUST BE UNPACKED AND PREPARED (INCL MOUNTING OF FACE MASK) FOR IMMEDIATE USE BEFORE IT IS PLACED READY FOR USE IN EMERGENCY SITUATION - THE INTEGRITY OF KITS ISSUED FOR STORAGE READY FOR USE SHOULD BE INSPECTED AT REGULAR INTERVALS. CAUTION HAS BEEN GIVEN TO ALERT THE USER TO SWITCH TO MOUTH-TO-MOUTH RESUSCITATION IF EFFICIENT VENTILATION CANNOT BE OBTAINED WITH THE DEVICE. IT IS EVALUATED, THAT IF THE USER HAD ADHERED TO THE INSTRUCTIONS PROVIDED. THE LACK OF FACE MASK IN THE SPUR II PLACED READY FOR USE WOULD NOT HAVE GONE UNDETECTED, AND THE DEVICE WOULD NOT HAVE BEEN ASSUMED TO BE READY FOR USE.

    Description of Event or Problem · 1

    "PATIENT CODED SO CLINICIANS PULLED ONE OF OUR SPUR II BAGS, BUT THERE WAS NO MASK INSIDE. SOMEONE TOOK OFF TO GRAB A MASK. PATIENT EXPIRED A BIT AFTER USING BAG AND MASK." IN COMMUNICATION WITH FACILITY, IT IS UNKNOWN IF THE TIME DELAY OF MASK CONTRIBUTED. IT IS ALSO UNKNOWN IF THE BAG WAS SEALED OR IF THE MASK COULD HAVE BEEN REMOVED BY HOSPITAL PERSONNEL FOR OTHER USE. DESPITE SEVERAL ATTEMPTS TO F/U AND GET MORE INFO FROM THE FACILITY, WE HAVE NO FURTHER INFO ON THE INVESTIGATION CONDUCTED BY THE HOSPITAL - IF THE INVESTIGATION IS STILL ONGOING OR HAS BEEN CONCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282144 AMBU SPUR II SINGLE PATIENT USE RESUSCITATOR BTM AMBU A/S 520611000 1590523

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death