BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7 HANDHELD

    MDR report key: 4231893 · Received October 17, 2014

    Report

    Report Number
    2031172-2014-00332
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. TOUCHSCREEN WAS WORKING PROPERLY. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER NINE (9) MONTHS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFO WERE MADE. THE UNIT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFO IS OBTAINED OR THE DEVICE IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RADICAL-7 GOES INTO THE SPO2 SETTINGS SCREEN IMMEDIATELY AFTER ATTEMPTING TO GO TO THE HOME SCREEN. THE UNIT ENGAGES IN MONITORING. NO PT INCIDENT WAS REPORTED. ADDITIONAL INFO WAS RECEIVED ON 10/13/2014. AFTER POWERING UP, THE UNIT WOULD GO TO THE HOME SCREEN AND, AFTER A FEW SECONDS, IT WOULD CHANGE TO THE MAIN MENU SCREEN WITHOUT PHYSICAL CONTACT TO THE TOUCH SCREEN. AFTER USING THE HOME BUTTON, THE DEVICE WOULD GO TO THE HOME SCREEN AND, A FEW SECONDS LATER, WOULD RETURN TO THE MAIN MENU SCREEN WITHOUT ANY PHYSICAL CONTACT WITH THE TOUCH SCREEN. THIS CYCLE OCCURRED REPEATEDLY. THE CUSTOMER DIDN OT KNOW IF THE SETTINGS REMAINED UNCHANGED BECAUSE SHE DID NOT CHECK FOR THIS WHEN SHE EXPERIENCED THE REPORTED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662128 RADICAL-7 HANDHELD OXIMETER DQA MASIMO CORPORATION 23785

    Patients

    Seq Age Sex Outcome Treatment
    1