BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-97 PULSE CO-OXIMETER

    MDR report key: 18271250 · Received December 5, 2023

    Report

    Report Number
    3019388613-2023-00274
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 14, 2023
    Report Date
    November 14, 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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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).

    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: E1. INITIAL REPORTER POSTAL CODE EXCEEDED ALLOWABLE FIELD LENGTH, INITIAL REPORTER POSTAL CODE IS AS FOLLOWS: (B)(6). E1. INITIAL REPORTER PHONE NUMBER EXCEEDED ALLOWABLE FIELD LENGTH, INITIAL REPORTER PHONE NUMBER IS AS FOLLOWS: (B)(6). H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED. DURING THE INVESTIGATION, RECESSED PINS WERE OBSERVED ON THE TB20 CABLE CONNECTOR. THE RECESSED PINS RESULTED IN THE UNIT BEING UNABLE TO RECOGNIZE THE CABLE TO OBTAIN MEASUREMENTS. E1. INITIAL REPORTER POSTAL CODE EXCEEDED ALLOWABLE FIELD LENGTH, INITIAL REPORTER POSTAL CODE IS AS FOLLOWS: (B)(6). INITIAL REPORTER PHONE NUMBER EXCEEDED ALLOWABLE FIELD LENGTH, INITIAL REPORTER PHONE NUMBER IS AS FOLLOWS: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SPO2 KEEPS LOSING SIGNAL FOR THE RAD-97 DEVICE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SPO2 KEEPS LOSING SIGNAL FOR THE RAD-97 DEVICE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SPO2 KEEPS LOSING SIGNAL FOR THE RAD-97 DEVICE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123203 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