BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-97 PULSE CO-OXIMETER

    MDR report key: 18036242 · Received October 30, 2023

    Report

    Report Number
    3019388613-2023-00265
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    September 28, 2023
    Report Date
    October 6, 2023
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    MWI
    UDI-DI
    00843997012317
    PMA / PMN Number
    K212161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. THE DEVICE POWERED ON WITH A BLANK SCREEN AND ISSUED AN AUDIBLE AND VISUAL ALARM, HOWEVER THE DEVICE DID NOT LOSE POWER DURING TESTING. AN IMPROPERLY SEATED FLEX CABLE AND LOOSE TAPE AT THE AT CONNECTIVITY BOARD CAUSED THE BLANK DISPLAY AND ALARMS.

    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.

    Additional Manufacturer Narrative · 0

    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 (9738).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE RAD-97 UNIT WILL POWER ON, BUT WILL LOSE POWER QUICKLY. THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE RAD-97 UNIT WILL POWER ON, BUT WILL LOSE POWER QUICKLY. THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE RAD-97 UNIT WILL POWER ON, BUT WILL LOSE POWER QUICKLY. THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949798 RAD-97 PULSE CO-OXIMETER MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 15750 ALTON PKWY 9738 00843997012317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown