BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS-7 WI-FI KIT

    MDR report key: 13006622 · Received December 14, 2021

    Report

    Report Number
    3019388613-2021-00349
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 19, 2021
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    DQA
    UDI-DI
    00843997014106
    PMA / PMN Number
    K183697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: THE RETURNED DEVICE WAS EVALUATED. VISUAL INSPECTION FOUND THE EXTERNAL HOUSING WAS DAMAGED AND SEPARATED AND CONTAMINANT WAS OBSERVED ON THE CONNECTOR. THE UNIT DID NOT POWER ON WHEN BATTERY MODULE WAS DOCKED. INTERNAL INSPECTION FOUND THE INSTRUMENT BOARD WAS DAMAGED DUE TO PUSHED DOWN RRA CONNECTOR. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER ONE (1) YEAR WITH NO PREVIOUS REPORTED ISSUES RELATED TO THIS REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INTERMITTENT CONNECTION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INTERMITTENT CONNECTION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895017 RADIUS-7 WI-FI KIT OXIMETER DQA MASIMO - 15750 ALTON PKWY 26823 00843997014106

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown