BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONTO SPOT CHECK PULSE CO-OXIMETER

    MDR report key: 7671390 · Received July 9, 2018

    Report

    Report Number
    2031172-2018-00380
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Date of Event
    June 15, 2018
    Report Date
    June 15, 2018
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K091057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED. THE CUSTOMER'S ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE DIGITS. ZIP CODE IS AS FOLLOWS: (B)(6).

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. THE DEVICE WAS ABLE TO OBTAIN READINGS AND VISUALLY AND AUDIBLY ALARM WHEN ALARM LIMITS WERE BREACHED. THE VOLTAGE OF THE FAILED LED SEGMENTS WERE LOWER THAN KNOWN GOOD ONES. THE ISSUE WAS ISOLATED TO THE FAILED LED SEGMENTS. CUSTOMER'S COMPLAINT WAS DUPLICATED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER FIVE (5) YEAR WITH NO PREVIOUS REPORTED ISSUES RELATED TO THIS REPORTED EVENT. BRAND NAME WAS CORRECTED FROM "PRONTO-7 SPOT CHECK PULSE CO-OXIMETER" TO "PRONTO SPOT CHECK PULSE CO-OXIMETER." CATALOG NUMBER WAS CORRECTED FROM "9221" TO "9167." PMA/510K WAS CORRECTED FROM "K111403" TO "K091057".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISPLAY FAILURE WHEREIN THE SEGMENTED DISPLAY IS MISSING SEGMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISPLAY FAILURE WHEREIN THE SEGMENTED DISPLAY IS MISSING SEGMENTS. NO IMPACT OR CONSEQUENCES TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511770 PRONTO SPOT CHECK PULSE CO-OXIMETER OXIMETER DQA MASIMO - 40 PARKER 21762

    Patients

    Seq Age Sex Outcome Treatment
    1