BEUDAMED
    FDA Adverse Event Other Summary report: N

    BODYGUARD

    MDR report key: 2340202 · Received November 4, 2011

    Report

    Report Number
    3006967710-2011-00002
    Event Type
    Other
    Date Received
    November 4, 2011
    Report Date
    October 7, 2011
    Manufacturer
    CME AMERICA LLC
    Product Code
    FRN
    PMA / PMN Number
    K042696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CME AMERICA HAS REPORTED THIS EVENT AS A FOLLOW-UP TO MEDWATCH REPORT (B)(4). THE ACTUAL DEVICE HAS BEEN RETURNED TO CME AMERICA AND HAS BEEN EVALUATED. CME AMERICA TECHNICIANS DETERMINED THAT THE DEVICE FUNCTIONS WITHIN SPECIFICATION WHEN TESTED ACCORDING TO STANDARD TEST PROCEDURES.

    Description of Event or Problem · 1

    THE PURPOSE OF THIS MDR REPORT IS TO PROVIDE ADDITIONAL INFORMATION TO THE VOLUNTARY MED WATCH REPORT (B)(4). THE DEVICE DISTRIBUTOR TO THE MEDICAL FACILITY THAT EXPERIENCED THE EVENT, INCORRECTLY REPORTED IN THE MED WATCH REPORT THAT THIS EVENT RESULTED IN AN ADVERSE OUTCOME INCLUDING THE FOLLOWING: THE MANUFACTURER'S COMPLAINT INVESTIGATION CONFIRMED WITH THE USING CLINICIAN THAT THERE WAS NO ADVERSE ADVENT. THE MANUFACTURER'S COMPLAINT INVESTIGATION CONFIRMED WITH THE USING CLINICIAN THAT THERE WAS NO INJURY OR HARM TO THE PATIENT. THE MANUFACTURER'S COMPLAINT INVESTIGATION CONFIRMED THAT THE USING CLINICIAN DETERMINED THAT THE EVENT OUTCOME WAS NOT LIFE THREATENING. THE MAXIMUM OUTCOME THAT COULD OCCUR IS MINOR NAUSEA OR DIZZINESS. THE ABOVE ERRORS IN THE VOLUNTARY MEDWATCH SUBMITTED BY THE DEVICE DISTRIBUTOR, (B)(4), ARE DUE TO USE OF THEIR STANDARD REPORTING PRACTICES VERSUS USING ACTUAL INFORMATION FROM THE USER FACILITY. CME AMERICA'S COMPLAINT INVESTIGATION INCLUDED INTERVIEWS WITH KEY INDIVIDUALS ASSOCIATED WITH THE EVENT AT (B)(6) (THE DEVICE DISTRIBUTOR) AND THE USER FACILITY, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODYGUARD FRN (INFUSION PUMP) FRN CME AMERICA LLC BG 323

    Patients

    Seq Age Sex Outcome Treatment
    1