BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSUFFLATOR HEAT FR 45L/MIN

    MDR report key: 6177552 · Received December 15, 2016

    Report

    Report Number
    9611102-2016-00017
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 17, 2016
    Manufacturer
    RICHARD WOLF GERMANY (GMBH)
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RICHARD WOLF (B)(4) RECEIVED ACTUAL DEVICE FROM USER FACILITY ON 11/28/2016. INVESTIGATION/EVALUATION CURRENTLY IN PROCESS. REQUEST FOR MISSING INFORMATION (IE PATIENT INFORMATION) SENT TO FACILITY, NO RESPONSE AS OF 12/13/2016. (B)(4) CONSIDERS THIS REPORT OPEN, FOLLOW-UP REPORT TO BE SUBMITTED ONCE INVESTIGATION IS COMPLETE. (B)(4). EVALUATION CURRENTLY IN PROCESS.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1. THE FOLLOWING SECTIONS UPDATED/ADDED: PRODUCT PROBLEM, SUSPECT DEVICE, ALL MANUFACTURERS, DEVICE MANUFACTURERS. THE 2235021 INSUFFLATOR 45 HEAT FR 45L / MIN WITH SN (B)(4) HAS BEEN TESTED BY THE APPROPRIATE DEPARTMENT AND THE ERROR MESSAGE: 452-150-420 '"PNEUMATIC COMPONENT MALFUNCTION DETECTED". THE PRESSURE SENSOR OF THE FUNCTION BOARD 64352356 IS DEFECTIVE. THE ELECTRONIC PRESSURE SENSOR OF THE INSUFFLATOR GIVES A WRONG VOLTAGE VALUE OFF. THIS ERROR IS DETECTED AFTER THE DEVICE IS SWITCHED ON DURING THE SELF-TEST AND DISPLAYED AS AN ERROR MESSAGE IN THE DISPLAY. DUE TO THE ERROR DESCRIPTION OF THE CUSTOMER IS TO ASSUME A SPORADIC MISTAKE. THE 2235021 INSUFFLATOR 45 HEAT FR 45L / MIN WITH SN (B)(4) WAS PRODUCED ON 27MAR2014. THE PRODUCTION BATCH 1240832 CONSISTS OF A TOTAL OF (B)(4) INSUFFLATORS. TO THE CUSTOMER, THE 2235021 INSUFFLATOR 45 HEAT FR 45L / MIN WAS DELIVERED ON (B)(6) 2014 WITH THE SN (B)(4) UNDER THE ORDER NUMBER (B)(4). THE USER IS INFORMED OF THE POSSIBILITY OF A DEVICE DEFECT IN THE INSTRUCTIONS FOR USE OF THE INSUFFLATOR HIGHFLOW 45 2235 GA-A 274 / DE / 2016-04 (B)(4) / PDG 15-8210. IN ORDER TO DETECT ERRORS EARLY, THE MEASURES DESCRIBED IN CHAPTER 3 "COMMISSIONING" AND CHAPTER 4 "CHECKS" MUST BE OBSERVED AND CARRIED OUT BEFORE STARTING THE LAPAROSCOPY. DESPITE VARIOUS PROTECTION AND CONTROL FUNCTIONS INTEGRATED IN THE DEVICE CONCEPT, A DEVICE ERROR CAN NOT GENERALLY BE RULED OUT. FOR THERAPEUTIC USE, THEREFORE, AN EQUIVALENT REPLACEMENT MUST BE AVAILABLE BECAUSE OF POSSIBLE FAILURES. THE USER DID NOT ACT IN ACCORDANCE WITH THIS INSTRUCTION, SO HE HAD TO SWITCH TO THE CONSERVATIVE PROCEDURE BECAUSE NO EQUIVALENT DEVICE WAS AVAILABLE. POTENTIAL HAZARDS WERE TAKEN INTO ACCOUNT IN THE RISK ASSESSMENT E1-1 R05 WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE AND ASSESSED WITH AN ACCEPTABLE RISK. THIS RATING IS STILL VALID CONSIDERING THE CURRENT CASE. RICHARD WOLF (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(4) RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) SUBMITTING REPORT ON BEHALF OF (B)(4).

    Description of Event or Problem · 1

    RICHARD WOLF (B)(4) WAS NOTIFIED THAT AT THE BEGINNING OF A LAPAROSCOPIC RIGHT COLECTOMY THE SELF TEST OF THE DEVICE IN QUESTION DISPLAYED AN ERROR. THERE WAS NO BACK UP DEVICE AVAILABLE SO DOCTOR WENT TO AN ALTERNATIVE METHOD, AN OPEN SURGERY. NO NEGATIVE CONSEQUENCES FOR THE PATIENT REPORTED.

    Description of Event or Problem · 1

    FOLLOW UP #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825723 INSUFFLATOR HEAT FR 45L/MIN INSUFFLATOR HIF RICHARD WOLF GERMANY (GMBH) 2235021

    Patients

    Seq Age Sex Outcome Treatment
    1