BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPORT ADAPTER

    MDR report key: 18975117 · Received March 25, 2024

    Report

    Report Number
    1719232-2024-00002
    Event Type
    Death
    Date Received
    March 25, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 22, 2024
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY DID NOT RETURN THE ACTUAL DEVICE TO THE MANUFACTURER FOR INVESTIGATION AND EVALUATION. RETAINED SAMPLES FOR PRODUCTION LOTS SHIPPED TO THE USER FACILITY WERE EVALUATED FOR STRUCTURAL INTEGRITY. APPLICATION OF MODERATE LATERAL FORCE TO THE LIFEPORT BODY AND CONNECTIONS HAD NO EFFECT. THE LIFEPORTS REVIEWED WERE CONFIRMED TO MEET ALL PRODUCTION REQUIREMENTS AND SPECIFICATIONS. PRODUCTION RECORDS FOR THESE LOTS WERE REVIEWED WITH NO INDICATION OF PRODUCTION ISSUES. COMPLAINT RECORDS WERE EVALUATED FOR POTENTIAL SIMILAR EVENTS REPORTED, WITH NO SIMILAR EVENTS REPORTED IN THE 2 YEARS EVALUATED. DISCUSSIONS WITH USER FACILITY STAFF SUGGEST THE EVENT WAS UNLIKELY A RESULT OF DEVICE FAILURE, AND RATHER THE RESULT OF PREEXISTING PATIENT CONDITION. THE USER FACILITY INDICATED THEY EVALAUTED OTHER LIFEPORTS IN THEIR STOCK AND CONCLUDED THEY WERE "PRETTY STURDY" AND UNLIKELY TO HAVE RESULTED IN THE EVENT REPORTED. THE MOST LIKELY CAUSE OF THE LIFEPORT DAMAGE DESCRIBED BY THE USER FACILITY IS RELATED TO USER ERROR IN PATIENT MANAGEMENT WHERE THE LIFEPORT IS STRESSED AND CRACKED/BROKEN THROUGH MEDICAL PERSONNEL ACTION. HOWEVER, THE EXACT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    USER FACILITY INDICATED THEY A HAD LIFEPORT ADAPTER (LPA) BREAK ON A PATIENT WHERE THE LIFEPULSE HIGH FREQUENCY VENTILATOR INSERTS THE LPA. THE USER FACILITY INDICATED THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10977 LIFEPORT ADAPTER LIFEPORT LSZ BUNNELL, INC. 2.5 MM LPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death