BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ PLANTINUM MOD

    MDR report key: 2063199 · Received March 22, 2011

    Report

    Report Number
    9615050-2011-00178
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 23, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. NUMBER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A "BURNT POWER CORD." AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT'S FAMILY NOTED SPARKS COMING FROM THE MALE END OF THE AC POWER CORD. THE NURSE WAS NOTIFIED. THE NURSE UNPLUGGED THE AC POWER CORD FROM THE AC POWER OUTLET. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT, THE PATIENT'S FAMILY OR THE NURSE. THERE WAS NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, CHARRING AND MELTING WERE NOTED AT THE MALE END OF THE AC POWER CORD. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+ PLANTINUM MOD 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR PLUM A+ SOFTWARE MODULE, LIST #12097,SN (B)(4)