BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-97 PULSE CO-OXIMETER

    MDR report key: 18336385 · Received December 15, 2023

    Report

    Report Number
    3019388613-2023-00279
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 1, 2023
    Report Date
    November 22, 2023
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    MWI
    UDI-DI
    00843997012775
    PMA / PMN Number
    K212161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. THERE WAS NO DAMAGE OR DEFECTS OBSERVED DURING THE VISUAL INSPECTION. THE DEVICE PASSED ALL FUNCTIONAL TESTING AND WAS ABLE TO OBTAIN MEASUREMENTS WITH ALL THE ENABLED PARAMETERS. DURING THE INTERNAL INSPECTION, THE DEVICE HAD RECESSED PINS IN THE TB20 CABLE CONNECTOR. INITIAL REPORTER POSTAL CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, POSTAL CODE IS AS FOLLOWS: (B)(6). INITIAL REPORTER PHONE NUMBER EXCEEDED MAXIMUM ALLOWABLE DIGITS, PHONE NUMBER IS AS FOLLOWS: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING 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., OTHER, OTHER TEXT: INITIAL REPORTER POSTAL CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, POSTAL CODE IS AS FOLLOWS: (B)(6). INITIAL REPORTER PHONE NUMBER EXCEEDED MAXIMUM ALLOWABLE DIGITS, PHONE NUMBER IS AS FOLLOWS: (B)(6).

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: "UDI RELATED DATA QUALITY UPDATES ONLY." THIS CORRECTION UPDATES THE UDI INFORMATION, 510K NUMBER, AND MODEL NUMBER TO ENSURE ALIGNMENT WITH GUDID. THE 510K NUMBER IN GUDID WAS UPDATED TO K212161 TO CORRESPOND WITH MASIMO'S 4-DIGIT MODEL NUMBER (9797).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN "INTERMITTENT CONNECTION OF SATS LEAD". THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN "INTERMITTENT CONNECTION OF SATS LEAD". THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN "INTERMITTENT CONNECTION OF SATS LEAD". THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267563 RAD-97 PULSE CO-OXIMETER MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 15750 ALTON PKWY 9797 00843997012775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown