BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ SPANISH 110V

    MDR report key: 3963202 · Received May 27, 2014

    Report

    Report Number
    9615050-2014-03648
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 8, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    FA212-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELDS SERVICE ENGINEER PERFORMED TESTING AT THE USER FACILITY. DURING TESTING, THE FLUID SHIELD WAS FOUND TO BE DAMAGED AND FLUID SPILLAGE WAS NOTED. THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY SHIELD PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, THE FLUID SHIELD WAS FOUND TO BE DAMAGED AND FLUID SPILLAGE WAS NOTED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT WITH A NOTE THAT STATED "DAMAGED." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT 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
    310159 PLM A+ SPANISH 110V 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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