BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+PMP W/BSE MOD

    MDR report key: 4425523 · Received January 13, 2015

    Report

    Report Number
    9615050-2015-00076
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Date of Event
    January 1, 2014
    Report Date
    December 30, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MECHANISM IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 DURING WAVE 2 REMEDIATION AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF 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
    31275 PLM A+PMP W/BSE MOD 80FRN FRN HOSPIRA COSTA RICA LTD. NA N

    Patients

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