BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIGHTYSAT

    MDR report key: 6173406 · Received December 14, 2016

    Report

    Report Number
    2031172-2016-01423
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    November 17, 2016
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K150314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): THE RETURNED DEVICE WAS EVALUATED. DURING THIS TESTING THE UNIT WAS UNABLE TO POWER ON USING CUSTOMER SUPPLIED BATTERIES OR LAB STOCK BATTERIES. THE FLEX CABLE WAS VISUALLY INSPECTED UNDER A MICROSCOPE AND THE CABLE APPEARS TO BE CRACKED BETWEEN THE TOP AND BOTTOM MODULES. AN X-RAY IMAGE CONFIRMS THE CRACK EXTENDS TO THE COPPER TRACES IN THE FLEX CABLE. INITIAL REPORTER ZIP CODE EXCEEDED MAXIMUM ALLOWABLE DIGITS, ZIP CODE IS AS FOLLOWS: 310-0817, CORRECTED DATA:

    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. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED; AT FIRST, THE DISPLAYED VALUE OF SPO2 WAS LOW. (ACCORDING TO THE CUSTOMER'S REPORT, THE VALUE WAS APPROXIMATELY 85 %, DESPITE ATTEMPTED BY NOT ONLY PATIENT, BUT ALSO THE STAFF IN THAT INSTITUTION, THE VALUE HAS NOT BEEN CHANGED.) THEN, THEY REPLACED THE BATTERY FOR THE ABOVE ISSUE, HOWEVER, THE DEVICE DOES NOT TURNED ON AGAIN AFTER REPLACED. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824785 MIGHTYSAT OXIMETER DQA MASIMO - 40 PARKER 9707-1

    Patients

    Seq Age Sex Outcome Treatment
    1