BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER EDITI

    MDR report key: 4142653 · Received September 26, 2014

    Report

    Report Number
    9615050-2014-05379
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 12, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PIEZO IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 DURING TESTING AT THE USER FACILITY, THE DEVICE AUDIBLE ALARM SOUND HAD A DEAD SPOT WHEN TESTING THE FULL VOLUME RANGE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601305 PLUM A+ DRIVER EDITI 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SN (B)(4)| PLUM A+ SOFTWARE MODULE, LIST #20791