BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA3 MEDNET WIRELESS

    MDR report key: 2020403 · Received February 8, 2011

    Report

    Report Number
    9615050-2011-00063
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 12, 2011
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH A NOTE THAT STATED, "BROKE E626." NO SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. DURING TESTING AT THE USER FACILITY, THE DEVICE DISPLAYED E626 (AUDIBLE ALARM) WITHOUT SOUNDING AN AUDIBLE ALARM TONE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK