BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-5 PULSE OXIMETER

    MDR report key: 7688463 · Received July 13, 2018

    Report

    Report Number
    2031172-2018-00385
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 14, 2018
    Report Date
    June 20, 2018
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    UDI-DI
    00843997005517
    PMA / PMN Number
    K033296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE LOCAL FACILITY, BUT HAS NOT YET BEEN RECEIVED AT THE MAIN OFFICE FOR EVALUATION. ONCE THE DEVICE HAS BEEN RETURNED AND INVESTIGATED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. THE UNIT WAS VERIFIED OPERATIONALLY AND FUNCTIONALLY. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM WHEN ALARM LIMITS WERE BREACHED. THE FAILURE WAS ISOLATED TO A DEFECTIVE 7 SEGMENT DISPLAY COMPONENT ON THE SYSTEM BOARD. THE CUSTOMER'S COMPLAINT WAS DUPLICATED. 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. 510K WAS UPDATED FROM "K033998" TO "K033296."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS MISSING SEGMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS MISSING SEGMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527950 RAD-5 PULSE OXIMETER OXIMETER DQA MASIMO - 40 PARKER 25198 00843997005517

    Patients

    Seq Age Sex Outcome Treatment
    1