BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIASYS

    MDR report key: 1221871 · Received November 4, 2008

    Report

    Report Number
    2021710-2008-00094
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 31, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2008, CARDINAL HEALTH SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE ALLEGED INJURED NURSE. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORTED TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. THE FOLLOWING INFO CONCERNING THE INITIAL EVAL OF THE DEVICE IS A SUMMARY OF THE INFO PROVIDED BY THE CARDINAL HEALTH FIELD SERVICE REP. THE CARDINAL HEALTH FIELD SERVICE REP. EVALUATED THE DEVICE AND VERIFIED THAT THE DEVICE'S CART IS BROKEN AND THAT THE CART BROKE IN THE MIDDLE. THE CARDINAL HEALTH FIELD SERVICE REP. WAS NOT ABLE TO DETERMINE A ROOT CAUSE FOR THE CART BREAKING. THE CARDINAL HEALTH FIELD SERVICE REP. REPLACED THE DEVICE'S CART AND RAIN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE THAT THE UNIT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION THE DEVICE WAS RETURNED TO THE CUSTOMER'S CONTROL READY TO BE PLACED BACK INTO SERVICE. THE CARDINAL HEALTH FIELD SERVICE REP. REPORTED THAT AT THE TIME OF HIS SERVICE CALL THE USER FACILITY'S LEGAL DEPT WOULD NOT RELEASE THE BROKEN CART (STAND) FOR RETURN TO THE CARDINAL HEALTH. CARDINAL HEALTH ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE USER FACILITY FOR THE RETURN OF THE DEVICE'S BROKEN CART FOR EVAL, AS OF THE DATE OF THIS REPORT, THE CART HAS NOT BEEN REC'D.

    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. "OVER THE WEEKEND - THE BASE SECTION OF THE AVEA COMPREHENSIVE CART BROKE WHILE A NURSE WAS MOVING THE UNIT. THE AVEA FELL OVER AND THE NURSE REC'D MINOR INJURIES, HAS SINCE BEEN CLEARED TO RETURN TO WORK. THE STAND IS IN BIOMED, THEY WILL HOLD FOR EVALUATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VOLUME VENTILATOR CBK CARDINAL HEALTH 207, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other