BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSORMEDICS

    MDR report key: 1486492 · Received September 24, 2009

    Report

    Report Number
    2021710-2009-00040
    Event Type
    Other
    Date Received
    September 24, 2009
    Date of Event
    August 26, 2009
    Report Date
    September 24, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE END USER REPLACED THE ALLEGED DEFECTIVE AIR/O2 BLENDER WITH ONE FROM THEIR SPARE PARTS ON HAND. CARDINAL HEALTH TECHNICAL SUPPORT SPECIALIST HAS DETERMINED THAT THE REPORTED FAILURE CAN BE CAUSED BY THE END USER IF THE GAS SOURCE HOSE IS CONNECTED TO THE INCORRECT AIR/O2 BLENDER PORT. THE O2 AND AIR INPUT ON THIS AIR/O2 BLENDER ARE CLEARLY LABELED AS SUCH. THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE EVALUATIONS PERFORMED BY (B)(4) (3RD PARTY SERVICE COMPANY) AND CARDINAL HEALTH FAILURE ANALYSIS LAB. THE (B)(4) (3RD PARTY SERVICE COMPANY) PICKED UP THE AIR/O2 BLENDER FROM THE USER FACILITY AND NOTICED THAT THE CONTROL KNOB WAS MISSING. DURING THE (B)(4) EVALUATION THE AIR/O2 BLENDER PERFORMED TO FACTORY SPECS EVEN THOUGH IT WAS MISSING THE CONTROL KNOB. UPON RECEIPT AT THE FACTORY, THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECHNICIAN EVALUATED THE AIR/O2 BLENDER AND IDENTIFIED IT WAS MISSING THE CONTROL KNOB. ONCE A NEW CONTROL KNOB WAS INSTALLED THE AIR/O2 BLENDER OPERATED AS INTENDED AND NO OTHER PROBLEMS WERE FOUND. NO COMPONENT TREND HAS BEEN IDENTIFIED, AT PRESENT, THIS EVENT IS CONSIDERED TO BE AN ISOLATED INCIDENT. ADDITIONALLY, THIS FILE WILL BE TRENDED AS PART OF OUR MONTHLY TRENDING. NOTE: BASED ON THE MISSING AIR/O2 CONTROL KNOB: IF THE AIR/O2 BLENDER WAS SET TO 100% AND WHILE AT THAT SETTING THE KNOB BECAME LOOSE OR CAME OFF THEN, THE AIR/O2 BLENDER WOULD BE STUCK AT THE 100% SETTING AND FURTHER ADJUSTMENTS WOULD NOT BE POSSIBLE.

    Description of Event or Problem · 1

    (B)(4). ON 08/26/2009: "[NAME REMOVED] CALLED FROM ADVOCATE (B)(6) STATING THAT UNIT (B)(4) IS GIVING THEM PROBLEMS. BLENDER WAS NOT WORKING PROPERLY, THEY REPLACED THE BLENDER WITH ONE THAT THEY ALREADY HAD. THEY HAVE AN (B)(6) PT AND WOULD LIKE TO GET A REPLACEMENT UNIT ASAP AT NO CHARGE." ON 08/26/2009: "I SPOKE WITH [NAME REMOVED] (RT DIRECTOR) CONCERNING THE ISSUES. HE STATED THAT THE BLENDER WOULD NOT COME OFF OF 100% (LOW SOURCE GAS LIGHT ILLUMINATED) WHEN THE DIAL WAS MANIPULATED, SO THEY DID CHANGE IT OUT WITH THEIR BLENDER. THE (B)(6) PT IS NOW ON THE RENTAL 3100B."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73LSZ VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC. 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR "FISHER/PACKEL"| "INOVENT"