BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50-H1B

    MDR report key: 1106243 · Received May 30, 2008

    Report

    Report Number
    2023050-2008-00038
    Event Type
    Other
    Date Received
    May 30, 2008
    Date of Event
    December 11, 2007
    Report Date
    May 1, 2008
    Manufacturer
    *
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE UNIT PASSED ALL COMPREHENSIVE TESTS, FUNCTIONED NORMALLY AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED. IN ADDITION, THE HOSPITAL ELECTRICAL NETWORK WAS TESTED BY OUR REP AND 3KV ELECTRICAL SPIKES/SURGES WERE FOUND. PROTECTION AGAINST SURGES BY REGULATION IS ONLY UP TO 2KV. THE MOST LIKELY ROOT CAUSE FOR THIS ISSUE MAY BE DUE TO ELECTRICAL SURGE FROM THE HOSP NETWORK LINES. BECAUSE THIS FAILURE HAPPENED AT TWO OTHER HT50 (REPORTED UNDER IMPORTER REPORT# 2023050-2007-00049 AND 2023050-2008-00001) AT THE SAME HOSP AND APPROX AT THE SAME TIME, OUR ASSUMPTION IS THAT THE FAILURE IS RELATED TO THE HOSPITAL ENVIRONMENT.

    Description of Event or Problem · 1

    REPORTEDLY IN 2007, THE UNIT WAS RUNNING OK ON A PT; THEN AC WAS REMOVED TO TRANSPORT THE PT. NO BATTERY ALARM OR OTHER ABNORMALITY WAS OBSERVED. WHEN THE AC WAS RECONNECTED; THE UNIT STARTED CONTINUOUS ALARM; AND NO BUTTON ON THE FRONT PANEL RESPONDED TO TOUCH. THE UNIT WAS STILL RUNNING; AND IT COULD NOT BE TURNED OFF. PAW HIGH LED AND EXTERNAL POWER LED WERE SOLID ON; AND THE INTERNAL BATTERY LED WAS FLASHING. THE USER TRIED TO UNPLUG AND PLUG AC POWER; THE CONDITION REMAINED THE SAME. PLEASE NOTE THAT THERE WAS NO SERIOUS INJURY OR DEATH IN THE REPORTED INCIDENT. ADD'L INFO REC'D FROM THE USER FACILITY ON MAY 1, 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT50-H1B VENTILATOR CBK * HT50-H1B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *