BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 4142957 · Received September 12, 2014

    Report

    Report Number
    9615050-2014-05189
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 15, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    FA210-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "DURING TESTING, THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THIS WAS DUE TO THE BATTERY." THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SVC CTR FOR A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE ALARMED WARNING: REPLACE BATTERY ALARM. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SVC CTR, THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THIS ERROR OCCURS WHEN THE BATTERY CANNOT BE FULLY CHARGED WITHIN 8 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565399 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE: LIST #12097, SN (B)(4)