BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER NEW

    MDR report key: 4110528 · Received September 16, 2014

    Report

    Report Number
    9615050-2014-05240
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 27, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DID NOT PASS THE ALARM LOUDNESS TEST WITH A DEAD SPOT IN THE PIEZO. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A NOTE THAT STATED, "S301 MALFUNCTION ALARM." NO INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PT INFORMATION, 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. NO ADDITIONAL INFORMATION WAS PROVIDED. "E301 MALFUNCTION ALARM." UNIT FAILED PVT ALARM LOUDNESS TEST WITH A DEAD SPOT IN PIEZO, CONFIRMED E301 MALFUNCTION ALARM IN HISTORY LOG. PROBABLE CAUSE(S): PROBABLE CAUSE FOR PVT ALARM LOUDNESS TEST FAILURE AND E301 ALARM IS DUE TO BAD PIEZO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573982 PLUM A+ DRIVER NEW 80FRN FRN HOSPIRA COSTA RICA LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST #UNK, SN UNK