BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7

    MDR report key: 6211814 · Received December 28, 2016

    Report

    Report Number
    2031172-2016-01470
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: 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. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): , CORRECTED DATA: MFR NUMBER CORRECTED FROM 2031172-2017-00242 TO 2031172-2016-01470.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DEVICES ARE SWITCHING OFF. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859097 RADICAL-7 OXIMETER DQA MASIMO - 40 PARKER 21317

    Patients

    Seq Age Sex Outcome Treatment
    1