BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER NEW

    MDR report key: 4110056 · Received September 11, 2014

    Report

    Report Number
    9615050-2014-05169
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 20, 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
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT HAVE AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION AND DISPLAYED E301 (AUDIO ALARM FAILURE) ERROR CODE. PRIOR TO TESTING, THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT WITH A REPORT OF, E445 MALFUNCTION AT START UP. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562408 PLUM A+ DRIVER NEW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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