BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ - ANIMAL HEA

    MDR report key: 4454750 · Received January 21, 2015

    Report

    Report Number
    9615050-2015-00140
    Event Type
    Malfunction
    Date Received
    January 21, 2015
    Date of Event
    January 2, 2015
    Report Date
    January 2, 2015
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE VETERINARY LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE LIST NUMBER LISTED IN THE "OTHER" FIELD. THE LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K011442. 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 THE DEVICE DOOR ROLLER PIN WAS BROKEN OFF. THE DEVICE WAS RETURNED FROM THE VETERINARY ICU DEPARTMENT TO AN UNSPECIFIED DEPARTMENT WITH A REPORT THAT THE DEVICE DOOR ROLLER PIN WAS BROKEN OFF. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS OR DELAYS IN 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
    47521 PLUM A+ - ANIMAL HEA UNK FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST #60530, (B)(4)