BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS-7 WI-FI KIT

    MDR report key: 14123182 · Received April 15, 2022

    Report

    Report Number
    3019388613-2022-00090
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    February 14, 2022
    Report Date
    March 22, 2022
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    MWI
    PMA / PMN Number
    K193242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. THE INVESTIGATION DETERMINED ALARMS WERE VISUAL BUT NOT AUDIBLE. NO DAMAGES WERE OBSERVED DURING THE INSPECTION HOWEVER A LOOSE CONTACT BETWEEN THE SPEAKER AND BATTERY BOARD LIKELY RESULTED IN THE SPEAKER NOT BEING AUDIBLE. D.1 COMMON DEVICE NAME WAS OXIMETER, IS MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS). D.4 THE DEVICE WAS LISTED AS CATALOG NUMBER 9664, ACTUAL IS 4195 WHICH IS NOT A FINISHED MEDICAL DEVICE.; UDI WAS (B)(4), ACTUAL IS (B)(4). 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 THE DEVICE HAS A SPEAKER FAULT, ALARM WON'T SOUND. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE HAS A SPEAKER FAULT, ALARM WON'T SOUND. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172037 RADIUS-7 WI-FI KIT MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 15750 ALTON PKWY 24949

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown