BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSORMEDICS

    MDR report key: 1122358 · Received August 15, 2008

    Report

    Report Number
    2021710-2008-00068
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    July 18, 2008
    Report Date
    August 15, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    BZC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION CONCERNING THE EVALUATION PERFORMED BY THE USER FACILITY WAS DERIVED FROM A FAX FROM THE USER FACILITY'S RESPONSE TO A LETTER SENT BY CARDINAL HEALTH SEEKING ADDITIONAL INFORMATION. THE USER FACILITY FEELS THAT THE SHOCK FELT BY THEIR TECHNICIAN WAS MOST LIKELY RELATED TO ESD FROM THE WALL TO WALL CARPET BECAUSE THERE IS NO CURRENT RUNNING THROUGH THE GROUND SHEATH. THE REPORT OF FRAYED CABLE IS A KNOW EVENT AND NO INVESTIGATION WILL BE PERFORMED. AN INVESTIGATION HAS ALREADY BEEN PERFORMED FOR A SIMILAR COMPLAINT AND ANOTHER INVESTIGATION IS NOT NECESSARY. THE CORRECTIVE OR PREVENTIVE MEASURES FOR THIS ISSUE RESIDE IN ENGINEERING CHANGE ORDER.

    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 REPRESENTATIVE. "CLAIMS THAT THIS CABLE ACTUALLY SHOCKED A TECHNOLOGIST WHEN HE GRABBED IT; SEES BROKEN WIRES -STATES HE KNOWS ELECTRICAL CURRENT IS GOING THROUGH -WANTS ALL OF HIS REPLACED IMMEDIATELY -SAYS WE SENT HIM A REPLACEMENT FOR ONE WITH ARTIFACT UNDER ORDER AND THIS REPLACEMENT IS WORKING BETTER, AND HE CAN CLEARLY SEE A BETTER DESIGN NOW - IS REQUESTING REPLACEMENT OF ALL 5. I HAVE DONE SO ON ORDER NUMBER". THE FOLLOWING ADDITIONAL INFORMATION CONCERNING THE EVENT WAS COPIED FROM A FAX RECEIVED FROM THE USER FACILITY ON 08/11/2008, IN RESPONSE TO A LETTER SENT BY CARDINAL HEALTH SEEKING ADDITIONAL INFORMATION. "THE CABLE HAD PULLED AWAY FROM THE MULTI-PIN CONNECTOR, EXPOSING BARE GROUND SHEATH. THE TECHNICIAN CLAIMED HE FELT A SHOCK MOST LIKELY ESD FROM THE WALL TO WALL CARPET. NO CURRENT CARRIED IN THIS WIRE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS SLEEP ANALYSIS SYSTEM BZC CARDINAL HEALTH 207, INC. 41 SOMMONSTAR Z4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other