BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVOS

    MDR report key: 22060397 · Received May 21, 2025

    Report

    Report Number
    2936999-2025-00255
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    August 30, 2023
    Report Date
    May 21, 2025
    Manufacturer
    JIANGYIN SINBON ELECTRONICS CO LTD
    Product Code
    MUD
    UDI-DI
    10884521780125
    PMA / PMN Number
    K182868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE CABLE OF THE UNIT WAS DEFECTIVE. IT WAS REPORTED THAT THE CABLE WAS DEFECTIVE AND THE PRODUCT DID NOT SEND COMMUNICATIONS. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO COMPONENT FAILURE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED AS PART OF REMEDIATION ACTIVITIES ASSOCIATED WITH CAPA # 643143, WHICH IS ADDRESSING MDR REPORTING GU IDANCE FROM FDAS 1995 PREAMBLE, WHICH ENSURES COMPLAINTS RELATED TO CORRECTIONS AND RECALLS WHICH WERE PREVIOUSLY REPORTED TO FDA UNDER 21 CFR 806 ARE NOW REPORTED AS MDRS ; THIS IS NOT A NEW MALFUNCTION/EVENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, PRIOR TO USE, AFTER COMPLETING SOFTWARE UPGRADE, THE CABLE FOUND FAULTY AND DID NOT RECOGNIZE THE LEFT SIDE OF PREAMPLIFIER. THE UNIT WAS POWER CYCLED AND THE CABLE WAS REPLACED TO ISOLATE THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724242 INVOS OXIMETER, TISSUE SATURATION MUD JIANGYIN SINBON ELECTRONICS CO LTD PMAC71RSC 20230428 10884521780125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown