BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1282674 · Received November 26, 2008

    Report

    Report Number
    2021710-2008-00103
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 26, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR (THIRD PARTY SERVICE COMPANY)) DID NOT SUBMIT A USER FACILITY/DISTRIBUTOR REPORT TO THE MANUFACTURE. (THIRD PARTY SERVICE COMPANY)). RESULTS: MAIN HARNESS ALARM SPEAKER CONNECTION WAS NOT PROPERLY CRIMPED. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH. THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECHNICIAN EVALUATED THE DEVICE AND WAS ABLE TO REPRODUCE THE REPORTED EVENT. THE FAILURE ANALYSIS LAB TECH VISUALLY INSPECTED THE DEVICE AND IDENTIFIED POOR CRIMPING ON MAIN HARNESS ALARM SPEAKER CONNECTOR CAUSING THE REPORTED EVENT. THIS IS A CARDINAL HEALTH OWNED DEVICE. THE DEVICE WILL BE REPAIRED AND RAN THROUGH A COMPLETE CHECKOUT AND CALIBRATION TO ENSURE THAT IT MEETS ALL FACTORY SPECS PRIOR TO ITS RETURN TO THE LOANER POOL. IN ADDITION A REVIEW OF TRENDED COMPLAINTS FOR THE PAST 6 MONTHS DOES NOT REVEAL A TREND ASSOCIATED WITH THE MAIN HARNESS, AT PRESENT THIS EVENT IS CONSIDERED TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECHNICAL SUPPORT MEDICAL SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A (THIRD PARTY SERVICE COMPANY) SERVICE TECH. "[NAME REMOVED] CALLED AND HE STATED THAT THIS UNIT JUST CAME FROM US AND IT DOES NOT HAVE AN AUDIBLE ALARM. HE TROUBLESHOOTED AND FOUND THAT IT'S ONE OF THE WIRES GOING TO THE ALARM. HE SAID THAT HE WIGGLED IT AND THE ALARM CAME ON FOR A FEW SECS THEN STOPPED AGAIN. HE SAID THAT HE CAN TAKE A PICTURE AND SEND IT TO ME. EXPLAINED TO HIM THAT I CAN SEE IF WE CAN GET THAT WIRING, BUT, IT'S DOUBTFUL. MAY JUST HAVE TO HAVE THE UNIT SENT IN FOR REPAIR. WILL FOLLOW UP WITH HIM WHEN HE WILL BE BACK IN THE OFFICE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA