BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGHFLOW INSUFFLATOR 45 EVAC + HEAT FR 45L/MIN

    MDR report key: 8809359 · Received July 19, 2019

    Report

    Report Number
    9611102-2019-00005
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Report Date
    June 17, 2019
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HIF
    PMA / PMN Number
    K991906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSUFFLATOR HIGHFLOW 45 EVAC WAS EVALUATED IN ACCORDANCE TO THE APPLICABLE TEST INSTRUCTIONS AND ALSO UNDERWENT AN ENDURANCE TEST. THE EXAMINATION REVEALED NO DEFECTS WITH THE INSUFFLATOR HIGHFLOW 45 EVAC. THERE IS NO MALFUNCTION NOTED. WE HAVE EVALUATED THE POSSIBILITY OF SUCH DAMAGE AND ITS HAZARDS WITHIN OUR RISK ANALYSIS E1-1 R05. THE PROBABILITY OF OCCURRENCE, TAKING INTO ACCOUNT THIS EVENT, IS WITHIN THE ASSUMED ACCEPTABLE RANGE. THE INSUFFLATOR WITH THE SERIAL NUMBER (B)(6) WAS PRODUCED ON JUNE 25, 2018. THE PRODUCTION BATCH 1384762 CONSISTS OF 12 INSUFFLATO-REN IN TOTAL. THE USER WAS INFORMED ABOUT THE POSSIBILITY OF A DEVICE DEFECT IN THE INSTRUCTIONS FOR USE FOR THE INSUFFLATOR HIGHFLOW 45 2235 GA-A 274 / EN / 2016-04 V5.0 / PDG 15-8210. IN ORDER TO DETECT FAULTS AT AN EARLY STAGE, THE MEASURES DESCRIBED IN CHAPTER 3 "COMMISSIONING" AND CHAPTER 4 "CHECKS" MUST BE OBSERVED AND CARRIED OUT BEFORE STARTING THE LAPAROSCOPY. DESPITE VARIOUS PROTECTIVE AND CONTROL FUNCTIONS INTEGRATED IN THE DEVICE CONCEPT, A DEVICE ERROR CANNOT GENERALLY BE RULED OUT. FOR THERAPEUTIC USE, AN EQUIVALENT REPLACEMENT MUST THEREFORE BE AVAILABLE BECAUSE OF POSSIBLE FAILURES. RICHARD WOLF GMBH(RWGMBH) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWGMBH RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA.

    Additional Manufacturer Narrative · 1

    A QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN MORE DETAILED INFORMATION ABOUT WHAT HAPPENED IN THE CASE. NOTE: THIS DEVICE REPORTED HERE WITH THE PRODUCT TYPE NUMBER 2235.031 IS NOT SOLD IN USA. HOWEVER, AN EQUIVALENT DEVICE IS MARKETED IN THE USA WITH THE PRODUCT TYPE NUMBER 2235.631. THE DEVICE IS AVAILABLE FOR EVALUATION, AND WAS RETURNED TO RICHARD WOLF ON JUNE 17, 2019, AND THE INVESTIGATION IS ON-GOING. THE CUSTOMER WILL BE PROVIDED WITH A LOAN DEVICE WHILE THE DEFECTIVE DEVICE IS BEING INVESTIGATED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    ON JUNE 17, 2019, RICHARD WOLF (B)(4) RECEIVED AN INSUFFLATOR FOR REPAIR. THE CUSTOMER REPORTED THAT THE DEVICE SWITCHES ITSELF OFF DURING USE OR THE DISPLAY GOES OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600275 HIGHFLOW INSUFFLATOR 45 EVAC + HEAT FR 45L/MIN HIGHFLOW INSUFFLATOR 45 EVAC + HEAT FR 45L/MIN HIF RICHARD WOLF GMBH 2235.031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other