BEUDAMED
    FDA Adverse Event Death Summary report: N

    PNEUMO SURE XL HI-FLOW INSUFFLATOR

    MDR report key: 3845797 · Received May 29, 2014

    Report

    Report Number
    MW5036388
    Event Type
    Death
    Date Received
    May 29, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HIF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR LAPAROSCOPIC HIATAL HERNIA REPAIR, NISSEN, AND LAP CHOLECYSTECTOMY. ANESTHESIA INDUCTION DONE WITHOUT INCIDENT. ABDOMEN WAS INSUFFLATED WITH CO2 AT 0731. AT 0733, PT WAS PULSELESS, NO O2 SAT, ETCO2 =15. PT IN PEA WITH THREADY CAROTID PULSE <30 SEC. CHEST COMPRESSIONS STATED AND ACLS PROTOCOL INITIATED. ABDOMEN OPENED AND EXPLORED WITH NO BLEEDING NOTED. PT TRANSFERRED TO (B)(6) HOSPITAL BY PARAMEDICS. PT EXPIRED IN ED. CASE REPORTED TO MEDICAL EXAMINER-FAMILY REFUSED AUTOPSY. BIOMED CALLED TO EVALUATE STRYKER INSUFFLATOR (B)(4) 2014. BIOMED REPORTED THAT INSUFFLATOR WAS DEFECTIVE. CO2 SETTING WAS SET AT 151/MIN HOWEVER, ACTUAL PRESSURE AT 38MMHG AND GOING AS HIGH AS 51MMHG. INSUFFLATOR QUARANTINED AND REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316776 PNEUMO SURE XL HI-FLOW INSUFFLATOR HI FLOW INSUFFLATOR HIF STRYKER ENDOSCOPY 620-040-610 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death