BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON ANESTHESIA CARE

    MDR report key: 3055572 · Received March 15, 2013

    Report

    Report Number
    3009662297-2013-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MCKESSON TECHNOLOGIES INC.
    Product Code
    BSZ
    PMA / PMN Number
    K113633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPANY WAS NOT ABLE TO DUPLICATE THE ALLEGED PROBLEM, FURTHER INVESTIGATION AND ANALYSIS THROUGH SIMULATED TESTING DETERMINED THAT THE MALFUNCTION IS LIKELY THE RESULT OF ABNORMAL LATENCY DELAYS EXPERIENCED DUE TO THE CUSTOMER'S DELAYED WORKSTATION AND NETWORK CONNECTIVELY DURING PATIENT CASE DATA UPDATES. IT WAS DETERMINED THAT THE USER OPENED A NEW PATIENT CASE RECORD ON THE SAME WORKSTATION BEFORE THE PRIOR RECORD UPDATE WAS COMPLETED, THEREBY RESULTING IN THE NEWLY OPENED CASE DISPLAYING INFORMATION FROM THE PREVIOUS PATIENT CASE BEING UPDATED. THE ANALYSIS AND TESTING DETERMINED THAT THE ALLEGED EVENT IS ISOLATED AND UNLIKELY TO OCCUR WITH ANY POTENTIAL PATIENT INJURY TO BE REMOTE, IF NOT IMPROBABLE. AS A PRECAUTIONARY MEASURE, THE COMPANY IS ADVISING ALL CUSTOMERS POTENTIALLY AFFECTED BY THE MALFUNCTION AND WILL PROVIDE A MITIGATIVE SOFTWARE UPDATE.

    Description of Event or Problem · 1

    IT WAS LEARNED FROM ONE CUSTOMER SITE OF AN OCCURRENCE WHERE THE DATA DISPLAYED DID NOT MATCH THE ACTUAL PATIENT DATA WHEN THE CASE WAS RECALLED IN THE ANESTHESIA CARE RECORD (ACR) AS THE DISPLAYED DATA INCLUDED DATA FROM ANOTHER CASE. THERE WERE NO ADVERSE EVENTS OR PATIENT INJURIES RESULTANT FROM THE REPORTED ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110322 MCKESSON ANESTHESIA CARE BSZ MCKESSON TECHNOLOGIES INC. MAC 14.3.1/14.3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention