BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MGE SNG

    MDR report key: 3901992 · Received May 7, 2014

    Report

    Report Number
    9615050-2014-03274
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 26, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    Z-1169-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, LEAKAGE WAS NOTED FROM THE DISPOSABLE BATTERIES IN THE BATTERY COMPARTMENT OF THE DEVICE. THE CUSTOMER CONTACT'S REPORTED ALARM CONDITION WAS DUPLICATED DURING TESTING. THE PROBABLE CAUSE WAS DUE TO A WORN ROLLER CLUTCH, ROLLER CLUTCH RETAINER, AND CAMSHAFT. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THEIR INFORMATION 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 DURING ROUTINE TESTING THE DEVICE ALARMED WITH A 099-007-036 (MOTOR NOT TURING WHEN IT SHOULD BE) SERVICE ALARM CODE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER LEAKAGE WAS NOTED FROM THE DISPOSABLE BATTERIES IN THE BATTERY COMPARTMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276869 GEMSTAR PAIN MGE SNG 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA