BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RD SET DCI

    MDR report key: 16357981 · Received February 10, 2023

    Report

    Report Number
    3019388613-2023-00024
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 16, 2023
    Report Date
    January 16, 2023
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    DQA
    PMA / PMN Number
    K180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: A TOTAL OF EIGHT (8) SENSORS AND CABLES WERE RETURNED AND EVALUATED. PART#: 4106-9, LOT#: 20KGE, DEVICE MANUFACTURER DATE: 10/5/2020, UNIQUE IDENTIFIER (UDI) #: (B)(4). THE CABLE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE CABLE WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. PART#: 4078-9, LOT#: 20JDM, DEVICE MANUFACTURER DATE: 10/6/2020, UNIQUE IDENTIFIER (UDI) #: (B)(4). THE CABLE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE CABLE WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. PART#: 4106-9, LOT#: 20KGE, DEVICE MANUFACTURER DATE: 10/5/2020, UNIQUE IDENTIFIER (UDI) #: (B)(4). AN OPEN IN CABLE ON THE WHITE CONDUCTOR WAS OBSERVED. THE CABLE FAILED CONTINUITY AND FUNCTIONAL TESTING. THE HOST DEVICE DISPLAYED AN ERROR MESSAGE AND AUDIBLY AND VISUALLY ALARMED DURING FUNCTIONAL TESTING. PART#: 4050, LOT#: 20J3W, DEVICE MANUFACTURER DATE: 9/29/2020, UNIQUE IDENTIFIER (UDI) #: (B)(4), PREMARKET (510K) NUMBER: K180046. TESTING FOUND CONTAMINATION AT THE CONNECTOR, CAUSING A DAMAGED TRACE AND RESULTING IN THE SENSOR HAVING AN OPEN CONNECTION. THE SENSOR FAILED CONTINUITY AND FUNCTIONAL TESTING. THE HOST DEVICE DISPLAYED AN ERROR MESSAGE AND AUDIBLY AND VISUALLY ALARMED DURING FUNCTIONAL TESTING. PART#:4078-9, LOT#: 22EZP, DEVICE MANUFACTURER DATE: 6/3/2022, UNIQUE IDENTIFIER (UDI) #: (B)(4). A BROKEN TAB FROM THE SENSOR STUCK INSIDE THE CONNECTOR OF THE CABLE, PREVENTING THE CABLE TO BE CONNECTED, WAS OBSERVED. UNABLE TO PERFORM CONTINUITY AND FUNCTIONAL TESTING AS A RESULT. PART#: 4050, LOT#: 20HWM, DEVICE MANUFACTURER DATE: 8/27/2020, UNIQUE IDENTIFIER (UDI) #: (B)(4), PREMARKET (510K) NUMBER: K180046. CONTAMINATION OF THE CONNECTOR WAS OBSERVED. CONTAMINATION ON PADS CAUSED MULTIPLE OPEN CONNECTIONS. THE SENSOR FAILED CONTINUITY AND FUNCTIONAL TESTING. THE HOST DEVICE DISPLAYED AN ERROR MESSAGE AND AUDIBLY AND VISUALLY ALARMED DURING FUNCTIONAL TESTING. ONCE THE CONTAMINATION CLEANED OFF, THE SENSOR BECAME ABLE TO FUNCTION AS DESIGNED. PART#: 4106-9, LOT#: 20GAX, DEVICE MANUFACTURER DATE: 8/4/2020, UNIQUE IDENTIFIER (UDI) #: (B)(4). BROKEN PIN AT THE ROUND 25 PINS CONNECTOR WAS OBSERVED. THE BROKEN PIN CAUSED AN OPEN CONNECTION. THE CABLE FAILED CONTINUITY AND FUNCTIONAL TESTING. THE HOST DEVICE DISPLAYED AN ERROR MESSAGE AND AUDIBLY AND VISUALLY ALARMED DURING FUNCTIONAL TESTING. PART#: 4078-9, LOT#: 20JDM, DEVICE MANUFACTURER DATE: 10/6/2020, UNIQUE IDENTIFIER (UDI) #: (B)(4). A BROKEN TAB FROM THE SENSOR STUCK INSIDE THE CONNECTOR OF THE CABLE, PREVENTING THE CABLE TO BE CONNECTED, WAS OBSERVED. UNABLE TO PERFORM CONTINUITY AND FUNCTIONAL TESTING AS A RESULT. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS:(B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT SPO2 DROP OUTS INTERMITTENTLY. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT SPO2 DROP OUTS INTERMITTENTLY. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997387 RD SET DCI OXIMETER DQA MASIMO - 15750 ALTON PKWY 4050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown RD RAINBOW SET MD20-12| RD RAINBOW SET R25-12