BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIWOMOBIL SYSTEM CART

    MDR report key: 14552767 · Received May 31, 2022

    Report

    Report Number
    1418479-2019-00051
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    August 23, 2019
    Report Date
    May 24, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FEM
    UDI-DI
    1100456370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. THIS MDR IS BEING SUBMITTED AS PART OF AN ONGOING RETROSPECTIVE REVIEW (REMEDIATION) OF PRIOR FILES BY RWMIC. INVESTIGATION REPORT FROM RICHARD WOLF MIC: PRODUCT APPEARANCE: SLIGHTLY USED. COMPLAINT CONDITION VERIFIED: YES, POSSIBLE LOOSE CONNECTION. REPEAT REPAIR: NO, NO PREVIOUS REPAIR HISTORY. MET SPECIFICATIONS: NO. TEST METHOD: FUNCTIONAL, VISUAL, ELECTRICAL. EQUIPMENT USED: MULTIMETER. PROBABLE ROOT CAUSE: OTHER, SEE CONCLUSION. PHYSICAL FINDINGS: CIRCUIT BREAKERS DAMAGED, POWER CORD NOT FULLY INSERTED INTO SOCKET, TEST CIRCUIT SWITCH WORKS INTERMITTENTLY. CONCLUSION: SEND TRANSFORMER ASSEMBLY TO RW GMBH FOR FURTHER INVESTIGATION. COMPLAINT VALID: YES. ACTION REQUIRED: SEND TRANSFORMER ASSEMBLY TO RW GMBH FOR FURTHER INVESTIGATION. THE RESULTS OF THE DEVICE INVESTIGATION BY RW GMBH: ONLY THE CONTROL MODULE PREMIUM 100V-120V (64014052, BATCH NUMBER 21199X0161) WAS RETURNED TO RICHARD WOLF GMBH (NOT THE WHOLE CART) FOR INVESTIGATION. THE CONTROL MODULE WAS EXAMINED BY RICHARD WOLF GMBH AND IT WAS FOUND THAT THE TWO CIRCUIT BREAKERS ON THE CONTROL MODULE WERE PRESSED IN FROM THE OUTSIDE WITH SOME OBJECT AND THUS DESTROYED. THE CONTROL MODULE WAS SENT TO THE SUPPLIER FOR INSPECTION / REPAIR. THE SUPPLIER LOOKED AT THE DAMAGE TO THE HOUSING. FROM THEIR POINT OF VIEW, IT IS IMPOSSIBLE FOR AN ASSEMBLY TO LEAVE THE FACTORY IN SUCH A CONDITION. THE DAMAGE ON THE SURFACE AND THE CONDITION OF THE CIRCUIT BREAKER HOLDER IN THE SLEEVE, WHICH IS PRESSED SOLIDLY INTO THE HOLDER, INDICATES DELIBERATE ACTION WITH CONSIDERABLE FORCE. THE SUPPLIER HAS PROVIDED TWO IMAGES SHOWING THE CIRCUIT BREAKER PIN IN THE NORMAL POSITION AND IN THE RELEASED STATE. IN THE ASSEMBLY SUPPLIED BY RICHARD WOLF GMBH FOR INVESTIGATION, HOWEVER, THE PINS HAVE BEEN FORCIBLY PRESSED IN; THEY NO LONGER WORK. IT WAS ALSO FOUND THAT THE CABLE SECURING BRACKET TO PREVENT THE POWER CORD FROM BEING PULLED OFF WAS INCORRECTLY ATTACHED, SO THAT A SECURE ELECTRICAL CONNECTION COULD NOT BE ESTABLISHED (THE POWER CORD COULD NOT BE FULLY INSERTED INTO THE SOCKET). THE CUSTOMER PROVIDED A VIDEO THAT SHOWED THAT THE INSULATION GUARD ONLY WORKED TEMPORARILY. SINCE THE INSULATION MONITOR WAS NOT AVAILABLE FOR EXAMINATION, IT IS NOT POSSIBLE TO DRAW A CLEAR CONCLUSION BASED ON THE VIDEO ALONE REGARDING THE INSULATION MONITOR. SINCE THE CIRCUIT BREAKERS ON THE CONTROL MODULE WERE DAMAGED AND THEREFORE HAD NO FUNCTION, IT IS POSSIBLE THAT THIS IMPAIRED THE FUNCTION OF THE INSULATION MONITOR, BUT THERE IS INSUFFICIENT INFORMATION TO DRAW A CLEAR CONCLUSION. THE CONCLUSION OF THE INVESTIGATION IS THAT A USER ERROR / HANDLING ERROR IS INDICATED. CAUTION! SYSTEM COMPONENTS MAY FAIL. IF THE DEVICE IS USED FOR THERAPEUTIC APPLICATIONS, ADEQUATE SYSTEM COMPONENTS MUST BE AVAILABLE AS A BACKUP. IMPORTANT! IN ADDITION TO THIS INSTRUCTION MANUAL, FOLLOW THE MANUALS FOR THE PRODUCTS USED IN COMBINATION WITH THIS PRODUCT. WARNING! WHEN THE MAXIMUM PERMISSIBLE POWER CONSUMPTION IS EXCEEDED, THE POWER SUPPLY MAY BE INTERRUPTED BY TRIGGERED FUSES OR CUTOUTS OF THE SYSTEM CART. DO NOT CONNECT ANY LIFE-PRESERVING OR LIFE-SUPPORTING DEVICES TO THE SYSTEM CART. PERMISSIBLE POWER CONSUMPTION: WARNING! WHEN THE MAXIMUM PERMISSIBLE POWER CONSUMPTION IS EXCEEDED, THE POWER SUPPLY MAY BE INTERRUPTED AS A RESULT OF TRIGGERED FUSES OR CUTOUTS IN THE SYSTEM CART. IF NEW COMPONENTS ARE CONNECTED, CHECK THE MAXIMUM POWER CONSUMPTION OF ALL SYSTEM COMPONENTS. PULL-OUT LOCK FOR POWER PLUG ON SYSTEM CART: WHEN THE POWER CABLE IS CONNECTED, THE CABLE SECURING BRACKET MUST ALWAYS BE INSTALLED. THE CABLE SECURING BRACKET PREVENTS THE POWER PLUG FROM BEING DISCONNECTED FROM THE SYSTEM CART INADVERTENTLY. FOR CONNECTING AND DISCONNECTING THE POWER PLUG (244009), LOOSEN THE CLAMPING SCREW AND THEN TIGHTEN AGAIN. TO GUARANTEE A SAFE ELECTRICAL CONNECTION ONLY THE POWER CABLES AND SECURING BRACKETS APPROVED BY RICHARD WOLF MAY BE USED. CHECKS: IMPORTANT! RUN THROUGH THE CHECKS BEFORE AND AFTER EACH USE. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. RETURN DAMAGED PRODUCTS TOGETHER WITH ANY LOOSE PARTS FOR REPAIR. DO NOT ATTEMPT TO DO ANY REPAIRS YOURSELF. VISUAL CHECK: CHECK THE RIWOMOBIL AS WELL AS THE DEVICES AND ACCESSORIES INSTALLED IN IT FOR DAMAGE, LOOSE OR MISSING PARTS, HYGIENE AND COMPLETENESS. CHECK ALL CONNECTION CABLES, TUBES AND HOSES FOR DAMAGE. ANY INSCRIPTIONS, LETTERING OR LABELING NECESSARY FOR THE SAFE INTENDED USE MUST BE LEGIBLE. MISSING INSCRIPTIONS, LETTERING OR LABELING LEADING TO WRONG HANDLING OR REPROCESSING MUST BE REINSTATED. FUNCTION CHECK: IMPORTANT! BEFORE YOU PERFORM THE FUNCTION CHECKS, MAKE SURE THAT THE DEVICES ARE IN PERFECT TECHNICAL CONDITION AND ARE SET UP CORRECTLY. THIS MUST ALSO BE GUARANTEED WITHIN THE SCOPE OF THE VISUAL CHECK. THE CABLE SECURING BRACKET FOR THE POWER INPUT CONNECTOR ON THE RIWOMOBIL POWER INPUT MUST BE INSTALLED. CHECK THAT ALL CONNECTION LINES ARE SECURELY CONNECTED. CARRY OUT A FUNCTION TEST OF THE INSULATION MONITORING CIRCUIT. CHECK THE RIWOMOBIL AS WELL AS THE DEVICES INSTALLED IN IT FOR PROPER FUNCTIONING USING THE CORRESPONDING INSTRUCTION MANUALS. INSULATION MONITORING CIRCUIT (OPTION): NOTE! THE INSULATION MONITORING CIRCUIT IS NOT USED AS A DEVICE IN ACCORDANCE WITH (B)(4) FOR MEDICALLY USED ROOMS OF GROUPS 1 AND 2. THE CIRCUIT ONLY EVALUATES THE CURRENT INSULATION RESISTANCE OF THE DEVICES CONNECTED TO THE RIWOMOBIL SYSTEM CART. IF THE INSULATION RESISTANCE DROPS BELOW A THRESHOLD VALUE OF 50 KOHM AN AUDIBLE AND VISIBLE ALARM IS TRIGGERED BUT THE SYSTEM CART IS NOT AUTOMATICALLY SHUT DOWN. IT IS NOT RECOMMENDED TO CONTINUE USING THE CART UNDER SUCH CIRCUMSTANCES. IT IS NECESSARY TO IMMEDIATELY INFORM THE TECHNICAL DEPARTMENT IN CHARGE ABOUT THE "INSULATION FAULT" OBSERVED, BECAUSE IT CANNOT BE EXCLUDED THAT THE USER AND THE DEVICES MAY BE ENDANGERED. FOR FURTHER DETAILS PLEASE SEE BROCHURE BBA 277-01. THE CIRCUIT MONITORS THE DEVICES CONNECTED TO THE SEPARATING TRANSFORMER FOR INSULATION FAULTS. IN THE CASE OF A FAULT, THE RED LED LIGHTS UP. IN ADDITION, AN ACOUSTIC SIGNAL IS SOUNDED WHICH, HOWEVER, CAN BE SWITCHED OFF. FAULT SIMULATION TEST: FUNCTION TEST OF THE INSULATION MONITORING CIRCUIT. THE RED LED LIGHTS UP, A SHORT SIGNAL IS SOUNDED. AFTER SUCCESSFUL COMPLETION OF THE TEST, THE LED WILL GO OUT. IN THE CASE OF A FAULT, THE RED LED BLINKS. IN ADDITION, AN ACOUSTIC SIGNAL IS SOUNDED WHICH, HOWEVER, CAN BE SWITCHED OFF. PLEASE OBSERVE THE FOLLOWING: CALL THE SERVICE TECHNICIAN IN CHARGE OR THE MANUFACTURER IN THE CASE OF A FAULTY SELF TEST. THE PERIOD 01/01/2016 TO 10/18/2019 WAS SUBJECTED TO A CLOSER LOOK AT THE COMPLAINTS DATABASE. (B)(4). THERE ARE NO SIMILAR COMPLAINTS. A PRODUCT OR BATCH DEFECT IS THEREFORE NOT RECOGNIZABLE. THE INVESTIGATED ISSUES DO NOT REPRESENT A GENERAL PRODUCT PROBLEM THAT INCLUDES A NON-CONFORMITY, NEGATIVE TREND OR PREVIOUSLY UNKNOWN HAZARDS. SINCE THE COMPLAINT RELATES TO A HANDLING ERROR, A SYSTEMIC PROBLEM IS NOT RECOGNIZABLE AND THE WARNINGS ACCORDING TO THE PROBLEM DESCRIBED BY THE CUSTOMER IN THE OPERATING INSTRUCTIONS GA-A 277 ARE CONSIDERED SUFFICIENT, NO FURTHER INVESTIGATION OR ACTION IS WARRANTED FOR THIS CASE, EXCEPT FOR THE MONITORING OF FURTHER CASES IN ORDER TO DETERMINE POSSIBLE TRENDS. RWMIC CONSIDERS THIS MDR CLOSED. SHOULD RW RECEIVE NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RICHARD WOLF, THAT "DURING THE CASE THE POWER SUPPLY WENT DOWN." ADDITIONAL DETAILS: DURING THE CASE, THE POWER SUPPLY WENT DOWN. IT WAS REPORTED THAT THE FAULT SIMULATION TEST FUNCTION FOR THE INSULATION MONITORING CIRCUIT WORKS INTERMITTENTLY AND THAT THE CIRCUIT BREAKERS ON THE CONTROL MODULE ARE BROKEN. THERE WAS NO REPORT OF ANY HARM OR HEALTH CONSEQUENCES FOR THE PATIENT OR THE HEALTHCARE FACILITY STAFF. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? GENERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328952 RIWOMOBIL SYSTEM CART CART FOR MEDICAL DEVICES FEM RICHARD WOLF GMBH 32116013 1100456370

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown