BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES

    MDR report key: 4203681 · Received July 22, 2014

    Report

    Report Number
    1218704-2014-00004
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    April 21, 2014
    Report Date
    July 12, 2014
    Manufacturer
    BIO-MED DEVICES, INC.
    Product Code
    BZR
    PMA / PMN Number
    K925982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER (B)(6) ( BIOMED DEPT TECH): DEVICE WAS REPAIRED (WITH PM AND CAL) BY (B)(4) OF CONTRACT SERVICE COMPANY UNIVERSAL HOSP SERVICES. HE FOUND THE BLENDER TO HAVE WATER INSIDE. THE DEVICE HAS BEEN RUN OFF A PORTABLE COMPRESSOR WHOSE WATER TRAP ("MOISTURE SEPARATING BOWL") HAD BEEN NEGLECTED, AND NOT EMPTIED. THE BLENDER IFU SPECIFIES THAT IT MUST BE USED ONLY WITH CLEAN, CRY MEDICAL GRADE GAS INPUTS. (B)(4) PLANS TO ADD A SECOND WATER TRAP (THAT AUTOMATICALLY DRAINS) TO THEIR SYSTEM. V.H.S. REPORTEDLY DID COMPLETE BLENDER OVER HAUL (WITH BMD PM KIT PARTS) AND CLEANED ALL CALCIUM BUILD UP INSIDE BLENDER. THIS BLENDER WAS NEVER SENT BACK TO THE MFR.

    Description of Event or Problem · 1

    SEE MEDWATCH REPORT # (B)(4) (WE ONLY RECEIVED REPORT FROM FDA, NOT THE USER - WE CONTACTED THE USER FACILITY THEREAFTER) INCORRECT OUTPUT OXYGEN % FROM BLENDER IN USE - NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428909 BIO-MED DEVICES AIR-OXYGEN BLENDER BZR BIO-MED DEVICES, INC. 2003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention