BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTLAB HYPERINFLATION SYSTEM

    MDR report key: 2644319 · Received June 29, 2012

    Report

    Report Number
    2246980-2012-00005
    Event Type
    Death
    Date Received
    June 29, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 29, 2012
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    NHK
    PMA / PMN Number
    K020281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR OUR INVESTIGATION. THE USER FACILITY RETURNED ANOTHER SAMPLE OF WHICH THE LOT NUMBER WAS UNK. THIS SAMPLE WAS EVALUATED AND RESULTS FOUND THAT WHEN THE EDGES OF THE TEAR LINES WERE MATCHED UP, A PIECE OF THE BAG WAS MISSING. THE MISSING PIECE CONTAINS JAGGED EDGES UNLIKE THE TORN SECTION. IT'S POSSIBLE THE TEAR BEGAN AT THIS POINT AND WAS CAUSED BY A KIND OF ABRASION OR PUNCTURE. THE TEAR WAS NOT CAUSED BY DEGRADATION AND THERE WAS NO EVIDENCE THAT THE BUSHING EDGES PIERCED THE BAG. ATTEMPTS WERE MADE TO RETRIEVE THE DETAILS OF THE INCIDENT AND THERE HAS BEEN NO RESPONSE TO-DATE. WITHOUT THE ACTUAL SAMPLE OR FURTHER DETAILS, IT IS INCONCLUSIVE AS TO HOW THE TEAR OCCURRED.

    Description of Event or Problem · 1

    CUSTOMER IS HAVING PROBLEMS WITH THE BAGS RIPPING DURING USE. DEATH UNDER INVESTIGATION BY (B)(6) OF THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTLAB HYPERINFLATION SYSTEM HYPER SYSTEM NHK VENTLAB CORPORATION 100672

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death