BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1009681 · Received March 7, 2008

    Report

    Report Number
    3023750-2008-00074
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 7, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MSX
    PMA / PMN Number
    K070204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER INFORMED US THAT THE ITEM WOULD NOT BE RETURNED FOR EVALUATION. THE ITEM IS A COMMERCIAL OFF-THE SHELF COMPUTER ACCESSORY (UNINTERRUPTIBLE POWER SUPPLY) MANUFACTURED BY POWERWARE.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE HOSPITAL CONDUCTED A GENERATOR TEST WHICH APPARENTLY LEAD TO LOSS OF POWER TO A COMPONENT OF THE CENTRAL PATIENT MONITORING SYSTEM. THE HOSPITAL'S BIOMEDICAL ENGINEER IDENTIFIED A UPS (UNINTERRUPTIBLE POWER SUPPLY) THAT HAD NOT MAINTAINED POWER DURING THE GENERATOR TEST. THE ENGINEER RESTORED POWER TO GIVE THE SYSTEM COMPONENT AND PATIENT MONITORING RESUMED. THE OUTAGE DURATION WAS ABOUT ONE HOUR AND 13 MINUTES. NO PATIENTS WERE ADVERSELY AFFECTED BY THE REPORTED PRODUCT PROBLEM. NOTE: FURTHER DETAILS FOR THE PATIENT IDENTIFIER WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY MSX WELCH ALLYN PROTOCOL, INC. ACUITY 7.01.00

    Patients

    Seq Age Sex Outcome Treatment
    1