BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVOS

    MDR report key: 20772488 · Received November 25, 2024

    Report

    Report Number
    2936999-2024-01813
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    November 6, 2024
    Report Date
    March 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3. CORRECTION: B5, D3. ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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

    D10 CONCOMITANT PRODUCTS: PMAC71DOC DOCKING STATION PMAC71DOC INVOS 7100 (SERIAL# (B)(6); PMAC71DOC DOCKING STATION PMAC71DOC INVOS 7100 (SERIAL# (B)(6); PMPAMP71 PREAMPLIFIER PMPAMP71 INVOS 7100 (SERIAL# (B)(6); PMPAMP71 PREAMPLIFIER PMPAMP71 INVOS 7100 (SERIAL# (B)(6); PMPAMP71 PREAMPLIFIER PMPAMP71 INVOS 7100 (SERIAL# (B)(6); PM7100 MONITOR PM7100 TABLET INVOS (SERIAL# (B)(6); PM7100 MONITOR PM7100 TABLET INVOS (SERIAL# (B)(6); PM7100 MONITOR PM7100 TABLET INVOS (SERIAL# (B)(6); PMAC71RSC SENSOR CABLE RE-USABLE PMAC71RSC INVOS (LOT# UNKNOWN); PMAC71RSC SENSOR CABLE RE-USABLE PMAC71RSC INVOS (LOT# UNKNOWN); PMAC71RIC REUSE INF SENSOR ADAPTER CABLE PM7100 (LOT# 20220225); PMAC71RIC REUSE INF SENSOR ADAPTER CABLE PM7100 (LOT# 20220225); PMAC71RSC SENSOR CABLE RE-USABLE PMAC71RSC INVOS (LOT# UNKNOWN); 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

    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

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

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD ERRATIC SPO2 READINGS RANGING FROM ZERO TO HIGH VALUES OF 70, 80, AND 90. FURTHERMORE, THE VALUE DISAPPEARED AND THE MONITOR WAS SHOWING AN ALARM OF 'LOW SOUND LEVEL.' THE MONITORS WERE ALSO CONNECTED THROUGH A MODULE TO A MONITOR BY A DIFFERENT MANUFACTURER. ONE CHANNEL ON THE MONITOR WAS SHOWING A FIXED VALUE OF 62, WHILE THE VALUE ON THE OTHER MONITOR WAS CHANGING. IN ADDITION STRANGE READINGS DEFINED AS CORRUPTED, CABLES AND PRE-AMPLIFIERS WERE USED ALONG WITH THE MONITOR AND VISUAL ALARM SHOWED IN YELLOW. THERE WAS NO SOUND/NO SIGNAL. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630470 INVOS OXIMETER, TISSUE SATURATION MUD JIANGYIN SINBON ELECTRONICS CO LTD PMAC71RSC 2021-08-11 10884521780125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE NOTES ON H11