BEUDAMED
    FDA Adverse Event Summary report: N

    CURLIN INFUSON PAINSMART IOD IV PUMP

    MDR report key: 2151486 · Received June 23, 2011

    Report

    Report Number
    1722139-2011-00103
    Date Received
    June 23, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: KNOWN PROBLEM. DEVICE IS IN PROCESS TO BE RECONFIGURED BACK TO ORIGINAL PAINSMART IOD CONFIGURATION ON (B)(4) 2011 AND THEN WILL GO THROUGH THE STANDARD YEARLY PM PROCESS. CONCLUSION: DURING THE NON-FACTORY RECERTIFICATION (NFR) PROCESS AT AUTHORIZED THIRD PARTY FACILITIES, THE NFR SOFTWARE CHANGES THE CONFIGURATION OF THE PUMP TO 6000CMS SO THE OPERATOR CAN TEST THE DEVICE. IF THE NFR PROCESS IS INTERRUPTED IN ANY WAY (POWER LOSS, PUMP IS DISCONNECTED FROM THE PC RUNNING THE NFR, ETC.), THE RECERTIFICATION PROCESS IS STOPPED AND THE DEVICE CONFIGURATION REMAINS AS THE 6000CMS MODEL TYPE. THERE ARE INSTRUCTIONS IN THE SERVICE MANUAL TO CONTINUE WITH THE NFR PROCESS IF IT IS STOPPED FOR ANY REASON. THE CONFIGURATION IS RECOVERABLE AT ANY TIME UNLESS A DIFFERENT PUMP IS CONNECTED TO THE NFR, AT WHICH POINT THE PUMP THAT WAS DISCONNECTED REMAINS AT 6000CMS CONFIGURATION. THE OPERATOR IN THIS CASE DID NOT FOLLOW THESE INSTRUCTIONS (PG. 23 OF TECHNICAL SERVICES MANUAL 350-9023). THE DEVICE EXTERIOR IS PAINSMART IOD, BUT THE DEVICE INTERNAL SOFTWARE SHOWS 6000CMS WHEN TURNED ON. THE DEVICE WAS NOT BEING USED BY A PT, IT WAS RECEIVING THE ANNUAL RECERTIFICATION AT THE TIME.

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION: "SHOULD BE IN EPIDURAL MODE, BUT WHEN IT POWERS UP IT SHOWS 6000CMS, FOUND DURING TESTING". PROBLEM FOUND DURING THE RECERTIFICATION (B)(4) PROCESS. DEVICE WAS NOT ON A PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1