BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL CEILING SUPPLY UNIT

    MDR report key: 9919469 · Received April 3, 2020

    Report

    Report Number
    3007417753-2020-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Report Date
    April 3, 2020
    Manufacturer
    MAQUET (SUZHOU) CO.,LTD.
    Product Code
    BYX
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INTRODUCTION: THE MEDICAL CEILING SUPPLY UNIT (ALSO AS PENDANT) MODUEVO ENERGY IS MADE UP OF A NUMBER OF MODULES THAT CAN BE CONFIGURED WITH ONE ANOTHER. DEPENDING ON THE MODULES USED, MEDICAL CEILING SUPPLY UNITS ARE DESIGNED FOR THE FOLLOWING PURPOSES: CARRYING AND POSITIONING OF MEDICAL DEVICES AND MONITORS. SUPPLY WITH MAINS VOLTAGE, COMPRESSED AIR AND MEDICAL GASES. ASPIRATION OF ANAESTHESIA GASES AND COMPRESSED AIR. ENERGY REFERS TO THE MOTORISED ARM WHICH CAN BE BOTH ROTATED AND ADJUSTED VERTICALLY USING THE MOTOR. THE MOTOR IS INSTALLED EITHER BETWEEN THE SPACER AND THE BEAM OR BETWEEN THE UPPER AND LOWER BEAMS. WE CAN ADJUST THE HEIGHT OF ENERGY BY PUSH AND HOLD THE BUTTON ON THE HANDLE. (REFER TO THE DESCRIPTION AS ATTACHMENT 01). HERE IS THE SUMMARY OF THE INVESTIGATION PERFORMED BY MAQUET. INVESTIGATION AT HOSPITAL. MAQUET FIELD SERVICE ENGINEER VISITED THE HOSPITAL AS PLANNED, IT'S CLARIFIED WITH THE HOSPITAL STAFF THAT THE AXIS COVER FELL DOWN AFTER HITTING UPPER ARM OF THE SAME PENDANT ( AS SHOWN IN ATTACHMENT 02) , RATHER THAN A NORMAL USE. THIS EVENT OCCURRED DURING HANDLING THE PENDANT, THE LOWER ARM STRUCK UPPER ARM WHICH CAUSED THE COVER DISLODGED AND DROPPED. THE COVER HIT A NURSE'S HEAD AND CAUSED A SLIGHT SCRAPE ON SKIN. NO MEDICAL TREATMENT WAS GIVEN AS IT'S A SLIGHT SKIN SCRAPE, NOW THIS NURSE IS FULLY RECOVERED . THE INVOLVED AXIS COVER WAS CHECKED BY FSE, IT'S FOUND IN NORMAL STATE AND NO DEFECT WAS IDENTIFIED. AFTER FSE REINSTALL THE COVER , PENDANT IS IN NORMAL USE. INVESTIGATION AT MAQUET (B)(4): MAQUET (B)(4) WENT THROUGH THE FOLLOWING RECORDS TO VERIFY IF THERE WAS ANY DEFICIENCY RELEVANT THE COVER FALLING OFF ISSUE PRIOR TO THIS COMPLAINT. MAQUET (B)(4) REVIEWED THE DHR FOR THE INVOLVED PENDANT, NO ABNORMALITY WAS FOUND RELEVANT TO THIS AXIS COVER DURING THE PRODUCTION AND INSPECTION. THE COMPLAINT HISTORY RECORD HAS BEEN REVIEWED AND NO FEEDBACK WAS RECEIVED RELEVANT TO THE INVOLVED PENDANT DURING INSTALLATION OR USE. MAQUET (B)(4) REVIEWED THE DESIGN OF THE AXIS COVER, AND FOUND THE MECHANICAL EVALUATION TESTING HAS BEEN PERFORMED ACCORDING TO IEC 60601-1. THE DESIGN OF THE COVER WAS DEMONSTRATED ROBUST FROM THE VERIFICATION TEST RESULT. MAQUET (B)(4) HAS CHECKED AND CONFIRMED MODUEVO ENERGY INSTRUCTIONS FOR USE (IFU 009001001 EN 07 2019-11-08), THE WARNING MESSAGE ' CARE SHOULD BE TAKEN DURING THE ENERGY¿S MOTORISED ARM LIFTING PROCESS TO AVOID COLLIDING WITH THE FALSE CEILING OR UPPER BEAM' IS INCLUDED IN THE IFU, BUT IT SEEMS NOT FULLY FOLLOWED IN THIS CASE. ACCORDING TO THE ABOVE INVESTIGATION, IT COULD BE CONCLUDED THE ROOT CAUSE IS THE COLLISION BETWEEN UPPER ARM AND LOWER ARM DUE TO THE NEGLIGENCE DURING OPERATION , WHICH PUT THE ABNORMAL EXTERNAL FORCE TO THE AXIS COVER THEN MADE IT OFF. REMEDIAL ACTION: MAQUET FIELD SERVICE ENGINEER CHECKED THE COVER AND FOUND IT'S IN A NORMAL CONDITION, SO IT'S FIXED BACK TO THE AXIS. THE ENGINEER VERIFIED THE PENDANT AND CONFIRMED IT'S IN NORMAL CONDITION, AND COULD BE PUT IN USE.

    Description of Event or Problem · 1

    HI, YESTERDAY I RECEIVED A MAIL THAT A COVER FROM THE ANESTHESIA SUSPENSION FROM MAQUET CAME DOWN AND INJURED A NURSE HANDLING THIS SUSPENSION. HE RECEIVED THIS PIECE ON HIS HEAD NEAR HIS EYE. HE IS FORTUNATELY NOT SERIOUSLY INJURED, JUST BRUISES AND SCRAPES. MAIL AND PICTURES IN ATTACHMENT. (PENDANT MODUEVO ENERGY REF; SU000200034) BEST REGARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384933 MEDICAL CEILING SUPPLY UNIT TUBING, PRESSURE AND ACCESSORIES BYX MAQUET (SUZHOU) CO.,LTD. MODUEVO(ENERGY) 7010012308

    Patients

    Seq Age Sex Outcome Treatment
    1