BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVOS

    MDR report key: 22062350 · Received May 21, 2025

    Report

    Report Number
    2936999-2025-00309
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    December 21, 2023
    Report Date
    September 2, 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
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: PMAC71RSC, SENSOR CABLE RE-USABLE PMAC71RSC INVOS (LOT#2023-04-28); PMAC71RSC, SENSOR CABLE RE-USABLE PMAC71RSC INVOS (LOT#2023-04-28); PMAC71RSC, SENSOR CABLE RE-USABLE PMAC71RSC INVOS (LOT#2023-04-28); PMAC71RSC, SENSOR CABLE RE-USABLE PMAC71RSC INVOS (LOT#2023-04-28); PMAC71RSC, SENSOR CABLE RE-USABLE PMAC71RSC INVOS (LOT#2023-04-28); PMAC71RSC, SENSOR CABLE RE-USABLE PMAC71RSC INVOS (LOT#2023-04-28); PMAC71RSC, SENSOR CABLE RE-USABLE PMAC71RSC INVOS (LOT#2023-04-28) 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, H3, H6, H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. IT WAS REPORTED THAT THE CABLE DID NOT WORK OUT OF THE BOX DURING INSTALLATION. THE CABLE WAS ISSUED WITH 1.0 SOFTWARE INSTEAD OF 2. AFTER CHECKING ALL MONITORS AND PRE-AMPS, IT WAS NOTED THAT THE LOT WAS PART OF AFFECTED PRODUCTS AND DID NOT WORK OUT OF THE BOX. WHEN THE CABLE WAS ATTACHED, THERE WERE NO READINGS AND GAVE AN ERROR THAT STATED TO REPLACE SENSOR. THE REPORTED ISSUE WAS NOT CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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, THE CABLE DID NOT WORK OUT OF THE BOX DURING INSTALLATION. THE CABLE WAS ISSUED ON 1.0 SOFTWARE INSTEAD OF 2. AFTER CHECKING ALL MONITORS AND PRE-AMPS, IT WAS NOTED THAT THE LOT WAS PART OF AFFECTED PRODUCTS AND DID NOT WORK OUT OF THE BOX. WHEN THE CABLE WAS ATTACHED, THERE WERE NO READINGS AND GAVE AN ERROR THAT STATED TO REPLACE SENSOR. THE SENSOR WAS REPLACED, THE PRE AMP WAS SWAPPED, AND THE CABLE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886609 INVOS OXIMETER, TISSUE SATURATION MUD JIANGYIN SINBON ELECTRONICS CO LTD PMAC71RSC 2023-04-28 10884521780125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown