BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 2980675 · Received February 22, 2013

    Report

    Report Number
    9615050-2013-00276
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    HOSPIRA COSTA RICA, LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION WHILE ON THE LOW VOLUME SETTING. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT THAT THE DOOR WAS BROKEN. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION WHILE ON THE LOW VOLUME SETTING. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77636 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA, LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST #20791, SN (B)(4)