BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EHP RFID MODULE

    MDR report key: 11761874 · Received May 3, 2021

    Report

    Report Number
    1216677-2021-00085
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    December 14, 2020
    Report Date
    March 10, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY IT COULD NOT BE DETERMINED WHEN THE COMPLAINT PRODUCT WAS MANUFACTURED BECAUSE THE LOT/SERIAL NUMBER OF THE COMPLETED UNIT WAS NOT PROVIDED. MANUFACTURING RECORD REVIEW A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT/SERIAL NUMBER OF THE COMPLETED UNIT WAS NOT PROVIDED. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE COMPLAINT PRODUCT LOT/SERIAL NUMBER BE PROVIDED GOING FORWARD, THE DEVICE HISTORY RECORD WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW 2-YEAR COMPLAINT HISTORY DID SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL AS THIS IS A FIELD SERVICE COMPLAINT. VISUAL EVALUATION THIS IS A FIELD SERVICE COMPLAINT, THERE WAS NO PRODUCT RETURNED FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE THIS INVESTIGATION WILL BE AMENDED ACCORDINGLY. FUNCTIONAL EVALUATION THIS IS A FIELD SERVICE COMPLAINT, THERE WAS NO PRODUCT RETURNED FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE THIS INVESTIGATION WILL BE AMENDED ACCORDINGLY. ROOT CAUSE THIS IS A FIELD SERVICE COMPLAINT, THERE WAS NO PRODUCT RETURNED FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE THIS INVESTIGATION WILL BE AMENDED ACCORDINGLY. ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AT THIS TIME. CORRECTION AND/OR CORRECTIVE ACTION THE ACTION IS TO CHANGE THE TABLET POWER SUPPLY AND USB HUB TO AN ALTERNATIVE TYPE, SURFACE PRO DOCKING STATION. SUBSEQUENT MEASUREMENTS, USING THE SURFACE PRO DOCKING STATION, INDICATE THAT THE LEVEL OF CHARGE IS LOW ENOUGH NOT TO BE FELT BY THE USER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS. THIS COMPLAINT WAS ADDRESSED IN THE FIELD, THE TECHNICIAN PERFORMED THE FOLLOWING: SERVICED BY PRODUCTION TEAM, DISTRIBUTOR TRAINING ISSUE. TRAIN PERSONNEL WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    MICROSOFT TABLET PSU STATIC SHOCK. MEMBERS OF THE EMBRYOLOGIST TEAM ARE EXPERIENCING STATIC SHOCKS TESTING HAS BEEN CARRIED OUT ON CHARGING POWER SUPPLY'S AND SURFACES IT HAS BEEN FOUND THAT ALL PSUS ARE PRODUCING A 17 VOLT AC VOLTAGE THROUGH THE USB THIS IS CAUSING THE EHP TO STATICALLY CHARGE UP THE PLATE AND IS BEING DISCHARGED THROUGH THE CUSTOMER WHEN THEY TOUCH THE METAL SIDE OF THE EHP CAUSING THEM TO JUMP THEY HAVE INFORMED ME THAT THE SHOCK IS ENOUGH TO POTENTIALLY CAUSE THEM TO DROP A DISH. I HAVE PLUGGED IN MY SURFACE PSU INTO ALL THE SURFACE LAPTOPS AND IT WORKS FINE NORMAL EXPECTED VOLTAGE FROM USB SOCKETS. 1216677-2021-00085-1 EHP RFID MODULE 5-70-801 E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 1

    (B)(6) TABLET PSU STATIC SHOCK. MEMBERS OF THE EMBRYOLOGIST TEAM ARE EXPERIENCING STATIC SHOCKS. TESTING HAS BEEN CARRIED OUT ON CHARGING POWER SUPPLY'S AND SURFACES IT HAS BEEN FOUND THAT ALL PSUS ARE PRODUCING A 17 VOLT AC VOLTAGE THROUGH THE USB THIS IS CAUSING THE EHP TO STATICALLY CHARGE UP THE PLATE AND IS BEING DISCHARGED THROUGH THE CUSTOMER WHEN THEY TOUCH THE METAL SIDE OF THE EHP CAUSING THEM TO JUMP THEY HAVE INFORMED ME THAT THE SHOCK IS ENOUGH TO POTENTIALLY CAUSE THEM TO DROP A DISH. I HAVE PLUGGED IN MY SURFACE PSU INTO ALL THE SURFACE LAPTOPS AND IT WORKS FINE NORMAL EXPECTED VOLTAGE FROM USB SOCKETS. ALL POWER SUPPLY UNITS NEED TO BE REPLACED 7 IN TOTAL. 09-12-2020. EHP RFID MODULE: 5-70-801. E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663766 EHP RFID MODULE EHP RFID MODULE LNX COOPERSURGICAL, INC. 5-70-801 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other