BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOOD MEDICAL

    MDR report key: 2621437 · Received June 14, 2012

    Report

    Report Number
    MW5025806
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Report Date
    May 10, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    (B)(6) MEDICAL CENTER CURRENTLY USES THE MOOG CURLIN PAINSMART AMBULATORY PUMP. THE TUBING FOR THIS DEVICE HAS BEEN ON RECALL SEVERAL TIMES THIS YEAR. THEIR SALES REPRESENTATIVE CONTACTED US TO UPGRADE THE SOFTWARE TO ADDRESS AN ADDITIONAL FDA RECALL FOR ERROR CODE 45. HE TOLD US THAT THEIR PUMPS WOULD HAVE TO BE RETURNED TO THE FACILITY BECAUSE THEY ARE EFFECTED BY ERROR CODE 17 AND CANNOT BE UPGRADED IN THE FIELD. I ASKED IF THE FDA KNEW OF THE ERROR 17 AND WHAT IT WAS AND HOW IT EFFECTED MY PUMPS AND HE WOULD NOT TELL ME. WE HAVE WAY TOO MANY OF THESE PUMPS TO SEND IN FOR AN UPGRADE. ADDITIONALLY, I WANT TO KNOW WHAT ERROR 17 CODE IS AND WHAT THEY ARE FIXING. I KNOW OF MANY OTHER HOSPITALS THAT HAVE BEEN TOLD THIS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOOD MEDICAL CURLIN PAINSMART FRN MOOG MEDICAL DEVICES GROUP CURLIN PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1