BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-530PA

    MDR report key: 7535106 · Received May 22, 2018

    Report

    Report Number
    8030229-2018-00164
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 23, 2018
    Report Date
    November 8, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921115091
    PMA / PMN Number
    K043517
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT DETAILS: THE CUSTOMER REPORTED ON (B)(6) 2018 THAT THE SPO2 VALUE SHOWED 10 TO 15-POINT VARIANTS WHEN COMPARED TO BLOOD GASES. SERVICE REQUESTED: TROUBLESHOOTING SERVICE PROVIDED: TROUBLESHOOTING INVESTIGATION RESULT: THE SN OF THE AFFECTED DEVICE IS NOT KNOWN. THE CUSTOMER WAS CONTACTED MULTIPLE TIMES BUT WOULD NOT RESPOND TO THE CALL/EMAIL TO TROUBLESHOOT THE ALLEGED MALFUNCTION, OR THE CUSTOMER DOES NOT WANT TO COOPERATE TO TROUBLESHOOT FURTHER. A REVIEW OF COMPLAINTS REGISTERED BY THIS FACILITY FOUND NO SIMILAR REPORTED ISSUES. SIMILAR COMPLAINTS USING "SPO2 READINGS" GAVE THE FOLLOWING RESULT: 49078- FALSE READINGS ON TRANSMITTER; ROOT CAUSE: USER ERROR 55933- ZM-530PA FALSE SPO2 READINGS; ROOT CAUSE: PENDING INVESTIGATION REVIEW OF COMPLAINTS FROM VA MEDICAL CENTER FOUND THE FOLLOWING TICKETS RELATED TO SPO2 ISSUE: 42885- SPO2 NOT WORKING; ROOT CAUSE: FIRMWARE UPGRADE NEEDED 23805- SPO2 PORT NOT WORKING; ROOT CAUSE: UNKNOWN BASED ON THE COMPLAINTS FROM CUSTOMER SITE AND SIMILAR SEARCH QUERY RESULT, NO ADVERSE TREND IS SUSPECTED WITH THE DEVICE. THE ROOT CAUSE OF THE ISSUE WAS UNABLE TO BE DETERMINED AS SUFFICIENT INFORMATION FROM THE CUSTOMER COULD NOT BE ATTAINED AND THE DEVICE WAS NOT RETURNED TO NK FOR EVALUATION/REPAIR. MODEL: TL-201T LOT # : NOT PROVIDED EXPIRATION: NOT PROVIDED UDI #: (B)(6). AGE OF DEVICE: NOT AVAILABLE MANUFACTURER DATE: NOT AVAILABLE PROBE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    THE NURSE MANAGER REPORTED THAT THE SPO2 MODULE ON THE TRANSMITTER DISPLAYED SP02 VALUES THAT WERE 10 TO 15 POINT VARIATIONS WHEN COMPARED TO THE BLOOD GASES.

    Additional Manufacturer Narrative · 1

    THE NURSE MANAGER REPORTED THAT THE SPO2 MODULE ON THE TRANSMITTER DISPLAYED SPO2 VALUES THAT WERE 10 TO 15 POINT VARIATIONS WHEN COMPARED TO THE BLOOD GASES. NIHON KOHDEN TS HAS MADE 3 SEPARATE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER WITH NO SUCCESS. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE NURSE MANAGER REPORTED THAT THE SPO2 MODULE ON THE TRANSMITTER DISPLAYED SPO2 VALUES THAT WERE 10 TO 15 POINT VARIATIONS WHEN COMPARED TO THE BLOOD GASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375880 ZM-530PA TRANSMITTER DRT NIHON KOHDEN CORPORATION ZM-530PA NOT APPLICABLE 04931921115091

    Patients

    Seq Age Sex Outcome Treatment
    1 SPO2 PROBE