BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 1021901 · Received March 28, 2008

    Report

    Report Number
    2021710-2008-00022
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 28, 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 SENT A LETTER TO THE USER FACILITY SEEKING ADD'L INFO CONCERNING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. THE USER FACILITY'S EVALUATED THE DEVICE AND WAS UNABLE TO REPRODUCE THE REPORTED EVENT. CARDINAL HEALTH ISSUED WITH USER FACILITY A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO RETURN THE DEVICE TO THE MFR FOR EVAL AND REPAIR. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RECEIVED BY THE MFR.

    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 USER FACILITY REP. "[NAME REMOVED] CALLED REQUESTING TO SEND THE UNIT IN FOR EVAL SECONDARY TO END-USER STAFF COMPLAINT OF THE UNIT NOT DELIVERING THE RIGHT CONCENTRATION OF FIO2 STAFF CHECKED THE UNIT WITH A ANALYZER: DAVE IS A BIO-MED, HE CHECKED THE UNIT OUT HE HAS NOT BEEN ABLE TO FIND THESE DISCREPANT BUT THE FACILITY WANTS THE UNIT SENT IN TO THE MANUFACTURE FOR EVAL. I WILL PROCESS."

    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