BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1120608 · Received August 13, 2008

    Report

    Report Number
    2021710-2008-00067
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 12, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH TECHNICAL SUPPORT SPECIALIST AND THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH. THE HILL-ROM (THIRD PARTY SERVICE COMPANY) SERVICE TECH IN CONJUNCTION WITH THE CARDINAL HEALTH TECH SUPPORT SPECIALIST DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS THAT THE DEVICE'S AIR/O2 BLENDER WAS FAULTY. HILL-ROM(THIRD PARTY SERVICE COMPANY) WAS SHIPPED A REPLACEMENT AIR/O2 BLENDER TO REPAIR THE DEVICE AND RETURN IT TO RENTAL SERVICE. THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH EVALUATED TO DEVICE'S AIR/O2 BLENDER AND VERIFIED THE COMPLAINT. THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH DETERMINED THAT THE ROOT CAUSE OF THE AIR/O2 BLENDER'S FAILURE WAS THAT THE FLAP (REED) ON THE ON THE REED PLATE IN THE ALARM ASSEMBLY WAS OUT OF POSITION AND DAMAGED. THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH DETERMINED THAT THE POSSIBLE ROOT CAUSE OF THIS OUT OF POSITION AND DAMAGE OF THE FLAP (REED) WAS POTENTIALLY DUE TO THE SOMEONE AT HILL-ROM (THIRD PARTY SERVICE COMPANY) ATTEMPTING TO ADJUST THE FLAP (REED) ON THE REED PLATE.

    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 REPRESENTATIVE. "[NAME REMOVE] CALLED AND WHILE TESTING THIS UNIT, THE BLENDER IS NOT ALARM WITH LOSS OF BOTH O2 AND AIR. WILL PLACE ORDER FOR BLENDER AND WILL HAVE DEFECTIVE ONE COME BACK FOR QA ANALYSIS. ORDER PLACED."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA