BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAN S31 FETAL HEART MONITOR

    MDR report key: 2594171 · Received September 17, 2010

    Report

    Report Number
    3004729605-2010-00012
    Event Type
    Other
    Date Received
    September 17, 2010
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT TOOK PLACE AT (B)(6), WHO ARE PARTICIPATING IN A (B)(6) RANDOMIZED CONTROLLED TRIAL. THE EVENT WAS REPORTED TO NEOVENTA AS A STUDY ADVERSE EVENT. A NEOVENTA REP VISITED THE HOSPITAL THE DAY AFTER THE EVENT WAS REPORTED, BUT WAS PREVENTED TO INVESTIGATE THE PRODUCT BY THE RISK MANAGEMENT OF THE HOSPITAL. DOCTOR (B)(6), HAS BEEN PROVIDING THE FOLLOWING UPDATE ON (B)(6) 2010: "THE OFFICIAL (RISK MANAGEMENT) REPORT DID NOT FIND A PROBLEM WITH STAN. THEY ARE STILL LOOKING INTO OPTIONS FOR OUTSIDE REVIEW. I FOUND OUT TODAY THAT RISK MANAGEMENT REPORTED THE EVENT TO THE FDA YESTERDAY. THE FDA ACKNOWLEDGMENT INDICATES THEY WILL MAKE CONTACT IF THEY DETERMINE THAT ADDITIONAL INFO IS NEEDED." NEOVENTA CONCLUDES THAT THE EVENT IS RELATED TO THE CONCOMITANT PRODUCT: (B)(4) LEG PLATE (B)(4). THE EVENT WILL THEREFORE BE REPORTED TO THE PRODUCER OF THIS PRODUCT: (B)(6).

    Description of Event or Problem · 1

    PT NOTED TO HAVE INFLAMMATION (DERMATITIS) ON RIGHT THIGH IN SHAPE OF FSE CABLE. AREA NOTED TO BE BLISTERED. PT ON STAN MONITOR FROM 15.55 (B)(6) 2010 UNTIL 11.00 (B)(6) 2010. NURSING STAFF ON POST PARTUM UNIT APPLYING A AND D OINTMENT AND KEEPING AREA CLEAN AND DRY. THE SUPERFICIAL PRESENTATION IS ANALOGOUS TO A 2ND DEGREE BURN WITH DESQUAMATION (= SHEDDING OF THE OUTERMOST LAYER OF THE SKIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAN S31 FETAL HEART MONITOR HEO: OBSTETRIC DATA ANALYZER HEO NEOVENTA MEDICAL AB SYS 101003

    Patients

    Seq Age Sex Outcome Treatment
    1 LEG PLATE (B)(4): (B)(4)