BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVOS

    MDR report key: 22061323 · Received May 21, 2025

    Report

    Report Number
    2936999-2025-00295
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    December 15, 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
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF REMEDIATION ACTIVITIES ASSOCIATED WITH CAPA # 643143, WHICH IS ADDRESSING MDR REPORTING GUIDANCE 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, DURING USE, CABLE HAD NO READINGS OR LOW READINGS. CHECKED ALL CABLES AND EACH ONE HAD A SIGNAL AND THEN ERROR CODE WILL COME UP TO CHECKED SENSOR. UNIT HAD NUMBER IN LOW TEENS, BUT MOSTLY THEY WILL SPIN FOR BASELINE AND WOULD GIVE THE BASELINE AND THEN SAY CHECK SENSOR AND DID NOT PROVIDE A NUMBER ANYMORE. HAVE ANOTHER CABLES WITH 2022 DATES AND TOOK ALL OF THOSE OUT OF SERVICE. SWAPPED SENSOR AND CABLES TO ISOLATE THE ISSUE. TRIED DIFFERENT MONITOR AND PRE-AMPS AND HAD INTERMITTENT SIGNAL. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937181 INVOS OXIMETER, TISSUE SATURATION MUD JIANGYIN SINBON ELECTRONICS CO LTD PMAC71RSC 2023-04-28 10884521780125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown