BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, RAD-97 PULSE CO-OXIMETER

    MDR report key: 9176526 · Received October 10, 2019

    Report

    Report Number
    3011353843-2019-00087
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 1, 2019
    Report Date
    October 8, 2019
    Manufacturer
    MASIMO - 52 DISCOVERY
    Product Code
    MWI
    UDI-DI
    00843997012317
    PMA / PMN Number
    K170168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. VISUAL INSPECTION UPON RECEIVING REVEALED A MISSING FOOT. THE DEVICE WAS ABLE TO TURN ON USING THE BATTERY. THE DEVICE WAS NOT ABLE TO USE AC POWER, WAS NOT ABLE TO CHARGE THE BATTERY, AND THE HOME BUTTON LED DID NOT ILLUMINATE TO INDICATE THE AC POWER WAS CONNECTED. INTERNAL INSPECTION OF THE DEVICE FOUND THE CAUSE TO BE A U5 POWER SUPPLY FAILURE ON THE CONNECTIVITY BOARD. THE DEVICE WAS ABLE TO TURN ON WHEN CONNECTED TO THE AC POWER; HOWEVER, THE DEVICE WAS USING THE BATTERY AND NOT THE AC. THE DEVICE WAS ABLE TO OBTAIN SPO2 AND PULSE RATE READINGS AND WAS FOUND TO VISUALLY AND AUDIBLY ALARM WHEN ALARM LIMITS WERE BREACHED. THE CUSTOMER COMPLAINT WAS NOT DUPLICATED AS THE DEVICE DID NOT SHUT DOWN BY ITSELF. 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., CORRECTED DATA: WAS UPDATED FROM 09/11/2019 TO 10/08/2019, WAS UPDATED FROM 01/01/1901 TO 09/01/2019.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE RAD-97 DEVICE INTERMITTENTLY SHUTS DOWN. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    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 · 1

    THE CUSTOMER REPORTED THE RAD-97 DEVICE INTERMITTENTLY SHUTS DOWN. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971359 KIT, RAD-97 PULSE CO-OXIMETER OXIMETER MWI MASIMO - 52 DISCOVERY 26242 00843997012317

    Patients

    Seq Age Sex Outcome Treatment
    1