BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS-7 WI-FI

    MDR report key: 17795170 · Received September 21, 2023

    Report

    Report Number
    3019388613-2023-00233
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 28, 2023
    Report Date
    August 28, 2023
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    MWI
    UDI-DI
    00843997014106
    PMA / PMN Number
    K153225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED RADIUS-7 WAS EVALUATED. THE INSTRUMENT MODULE LOST CONNECTION WITH THE BATTERY MODULE WITH MINIMAL PHYSICAL MANIPULATION. THE TOP COVER OF THE INSTRUMENT MODULE WAS LIFTED AND CAUSED THE DISRUPTION IN THE CONNECTION OF THE RADIUS-7 MODULE HALVES.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE RADIUS-7 MODULE "INTERMITTENTLY CUTS OUT."  THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE RADIUS-7 MODULE "INTERMITTENTLY CUTS OUT." THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457773 RADIUS-7 WI-FI MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 15750 ALTON PKWY 26971 00843997014106

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown