BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 1051179 · Received May 22, 2008

    Report

    Report Number
    2021710-2008-00049
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 21, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CARDINAL HEALTH ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE DISTRIBUTOR (SYRACUSE MEDICAL EQUIPMENT REPAIR (THIRD PARTY SERVICE CO)) FOR THE RETURN OF THE ALLEGED FAULTY SPARE PARTS FOR EVAL. AS OF THE DATE OF THIS REPORT, THE ALLEGED FAULTY SPARE PARTS HAVE NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A THIRD PARTY SERVICE COMPANY REP. "BLENDER ALARM REEDS DO NOT SOUND WITH AIR FLOW. REPLACEMENT PARTS OUT OF BOX FAILURE - NO PT INVOLVEMENT." THE THIRD PARTY SERVICE CO REPORTED THAT THEY HAD TWO PN: 05436, ALRM, BLNDR BYPASS ASSY, FAIL OUT OF BOX. THESE SPARE PARTS FOR THE BIRD MICROBLENDER WOULD NOT FUNCTION (EMIT AN AUDIBLE ALARM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD AIR/O2 BLENDER BZR CARDINAL HEALTH 207, INC BLENDER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA