BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIASYS

    MDR report key: 1321128 · Received February 19, 2009

    Report

    Report Number
    2021710-2009-00005
    Event Type
    Other
    Date Received
    February 19, 2009
    Date of Event
    January 21, 2009
    Report Date
    February 19, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE FOLLOWING INFORMATION CONCERNING THE EVAL OF THE DEVICE, WAS COPIED FROM THE FAILURE INVESTIGATION REPORT COMPLETED BY THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH ONCE THE EVAL WAS COMPLETE. "VISUALLY VERIFIED REPORTED ISSUE IN THE COMPLAINT. INSPECTED UNIT AND DISCOVERED BURN MARKERS ON THE VELA POWER SUPPLY PCBA (B)(4) WAS COMPLETELY BURN UP. VISUALLY INSPECTED THE UNIT AND FOUND NO DAMAGE OR BURNT COMPONENTS BESIDES THE ONES ON THE POWER SUPPLY (B)(4). INSPECTED BATTERY TRAY AND FOUND ONE OF THE BATTERY WAS NOT CENTERED IN THE TRAY, REMOVED BATTERY AND INSPECTED AREA, AND FOUND NO BURN MARKERS, FOUND A SCRATCH ON THE ONE THE BATTERIES, REMOVED BATTERY AND TEST VOLTAGE. VOLTAGE ON BATTERY WAS 13.5 VDC, ALSO TEST TO SCRATCH TO GROUND AND FOUND NO ISSUES. REPLACED POWER SUPPLY WITH KNOWN GOOD (B)(4) AND ALLOWED UNIT TO CHARGE FOR 6 HOURS AND POWERED ON UNIT WITH NO ISSUES, RAN UNIT FOR 4 HOURS WITH NO ISSUES. ISSUE IN THE COMPLAINT WAS CAUSED BY THE VELA POWER SUPPLY (B)(4) OVER CURRENTLY, WHICH CAUSE THE REPORTED ISSUE IN THE COMPLAINT BATTERY. THIS HAD NOTHING TO DO WITH THE ISSUE REPORTED, FOUND NO FAULTS WITH THE BATTERY TRAY OR BATTERIES." PER THE FAILURE ANALYSIS LAB, THE POWER SUPPLY WAS REPLACED, BY THE CARDINAL HEALTH SERVICE DEPARTMENT TECHNICIAN, IN ORDER TO ADDRESS THE REPORTED EVENT. AS A COURTESY TO OUR CUSTOMER, THE BATTERY TRAY CONTAINING COSMETIC DAMAGE WAS ALSO REPLACED. THE DEVICE WAS THEN TESTED THROUGH A COMPLETE CHECKOUT TO ENSURE IT MET ALL FACTORY SPECS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE. A REVIEW OF TRENDED COMPLAINTS FOR THE PAST 6 MONTHS DOES NOT REVEAL TREND ASSOCIATED WITH THE POWER SUPPLY ALLEGED FAILURE, AT PRESENT, THIS EVENT IS CONSIDERED TO BE AN ISOLATED INCIDENT. ADDITIONALLY, THIS FILE WILL BE TRENDED AS PART OF OUR MONTHLY TRENDING. FILE WILL BE CLOSED AND MAY BE REOPENED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. AC (2/19/2009).

    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 BIOMED TECHNICIAN. "[NAME REMOVED] IS A TRAINED BIOMED AND HAS WORKED ON THESE VELAS FOR YEARS. HE WAS REPLACING THE BATTERY TRAY HE HAD ORDERED AND FOUND THAT WHEN HE TRIED TO PUT THE COVER ON THE EVENT, THERE WAS ONE OF THE BATTERY PACKS SITTING UP COCKEYED IN THE TRAY. SO HE TRIED TO REPOSITION IT AND THERE WAS A FLASH AND SPARKS AND, THE POWER PCB CAUGHT FIRE. HE DISCONNECTED EVERYTHING AND, THE GLOWING AREA OF THE POWER PCB STOPPED BURNING. HE THEN INSPECTED THE BATTERY PACK AND COULD SEE THERE WERE MARKS AND CUTS IN THE BATTERY WRAPPING MATERIAL WHERE IT HAD MADE CONTACT WITH SOMETHING IN THE TRAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VENTILATOR, CONTINOUS (RESPIRATOR) CBK CARDINAL HEALTH 207, INC. VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA