BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAR

    MDR report key: 466635 · Received June 12, 2003

    Report

    Report Number
    2021710-2003-00191
    Event Type
    Malfunction
    Date Received
    June 12, 2003
    Date of Event
    April 28, 2003
    Report Date
    April 29, 2003
    Manufacturer
    BIRD PRODUCTS CORP.
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A COMPRESSOR POWERING A BEAR 1000 THAT FAILED WHILE ON A PT. THE COMPRESSOR HAD SOME WORK ON IT BY FIELD SERVICE AROUND 3/03 AND THE CONTACT WAS NOT SURE WHAT WAS DONE TO FIX IT NOR DID THEY HAVE MUCH INFO ON THE NATURE OF THIS COMPRESSOR FAILURE OTHER THAN IT DOESN'T WORK, EVEN MORE CONFUSING IS THAT THE SERIAL NUMBER THAT THEY PROVIDED IS LINKED TO BEAR 1000 NOT A COMPRESSOR. CO REP ASKED THEM TO GATHER ALL THE REQUIRED INFO, PT INJURY, CORRECT S/N SO THAT CO CAN CONDUCT A PROPER INVESTIGATION. THE INFO THAT THEY HAVE AT PRESENT TIME IS EXTREMELY LIMITED. CONTACT WAS GIVEN EXTENSION TO CALL DIRECT WHEN THEY HAVE ALL THE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR AIR COMPRESSOR BTI BIRD PRODUCTS CORP. BEAR 1000 COMPRESSOR *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN