BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 1001362 · Received February 20, 2008

    Report

    Report Number
    3023750-2008-00056
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 19, 2008
    Report Date
    January 21, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MLD
    PMA / PMN Number
    K972121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. EVALUATION OF THE DEVICE WAS PERFORMED BY THE CUSTOMER. CONCLUSION: THE CUSTOMER REPORTED THAT THEIR REPLACEMENT OF THE CPU'S INTERNAL POWER SUPPLY UNIT CORRECTED THE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILURE OF THE POWER SUPPLY THAT IS LOCATED INSIDE OF THE CPU (CENTRAL PROCESSING UNIT) OF A COMPUTER THAT IS PART OF THEIR ACUITY CENTRAL STATION PATIENT MONITORING SYSTEM. THE CUSTOMER FURTHER REPORTED THAT THEY REPLACED THE POWER SUPPLY AND SUCCESSFULLY RESTARTED THE MONITORING SYSTEM. PATIENT MONITORING WAS INTERRUPTED FOR ABOUT TWO HOURS WHILE THEY REPLACED THE POWER SUPPLY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING MLD WELCH ALLYN PROTOCOL, INC. ACUITY 5.20.04

    Patients

    Seq Age Sex Outcome Treatment
    1