BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A-PMP W/BSE MOD

    MDR report key: 4597451 · Received March 5, 2015

    Report

    Report Number
    9615050-2015-00549
    Event Type
    Malfunction
    Date Received
    March 5, 2015
    Date of Event
    February 1, 2015
    Report Date
    February 5, 2015
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K011442
    Removal / Correction Number
    Z-0624-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, IT WAS FOUND THAT THE DEVICE DOOR ROLLER PIN WAS BROKEN OFF AND THE DOOR ROLLER WAS MISSING. FURTHER TESTING FOUND THE DEVICE HAD UNRESTRICTED FLOW WHEN THE DOOR WAS OPENED. THIS WAS DUE TO THE MISSING DEVICE DOOR ROLLER AND BROKEN DOOR ROLLER PIN PREVENTED PROPER ACTUATION OF THE REGULATOR CLOSED ON THE DEVICE MECHANISM CAUSING UNRESTRICTED FLOW WHEN THE DOOR WAS OPENED. THE CUSTOMER'S REPORT OF THE DEVICE ALARMED FOR WARNING REPLACE BATTERY WAS CONFIRMED. AS INDICATED, THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE ALARMED FOR WARNING REPLACE BATTERY. NO ADD'L INFO WAS PROVIDED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THE DEVICE DOOR ROLLER PIN WAS BROKEN OFF AND THE DOOR ROLLER WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154635 PLM A-PMP W/BSE MOD 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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