BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA3 MEDNET WIRELESS

    MDR report key: 3983247 · Received July 3, 2014

    Report

    Report Number
    9615050-2014-04301
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 16, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE DID SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. AN INSPECTION FOUND PINS 3 AND 5 WERE LIFTED ON THE PIEZO. THIS WAS DUE TO THE PINS THAT WERE LIFTED FROM THE CONDUCTOR TRACE ON THE BOTTOM OF THE AUDIO TRANSDUCER WHICH DISABLED THE OUTPUT. THE CAUSE OF THE LIFTED PINS FROM THE CONDUCTOR TRACE ON THE AUDIO TRANSDUCER COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A NOTE THAT STATED, "PCA MALFUNCTION MAINTENANCE REQUIRED." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT AUDIBLY ALARM DURING AN ALARM CONDITION. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392034 PCA3 MEDNET WIRELESS 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK