BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE SCOPE G9

    MDR report key: 19530213 · Received June 13, 2024

    Report

    Report Number
    8030229-2024-04336
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 16, 2024
    Report Date
    September 11, 2024
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921112168
    PMA / PMN Number
    K213316
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE DATA FLICKERS ON THIS UNIT. ACCORDING TO THE CUSTOMER, THE NUMERICS START TO FLASH AND THEN SEEM TO RESET; HOWEVER, THE WAVEFORMS DISAPPEAR. THE ISSUE STARTED AFTER THE SOFTWARE WAS UPDATED TO VERSION 01-45 AND SUBSEQUENT DOWNGRADED BACK TO 01-40. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: MULTIPLE FOLLOW-UP REQUESTS WERE SENT TO THE CUSTOMER, BUT THEY WERE UNRESPONSIVE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE WE HAVE NOT RECEIVED THE LOGS FROM THE COMPLAINT DEVICE. D10 ATTEMPT # 1: (B)(6) 2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 (B)(6) 2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CU-192RA/G9: BSM-1700: MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NI. CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM CSM-1901 TO LIFE SCOPE G9. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM CSM-1901 TO CU-192R. D4 ADDITIONAL DEVICE INFORMATION / CATALOG #: CORRECTED THE CATALOG # FROM CSM-1901 TO CU-192RA. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. G4 PREMARKET IDENTIFICATION / PMA/510(K) NUMBER: CORRECTED THE 510(K) # FROM K151080 TO K213316. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE DATA FLICKERS ON THIS UNIT. ACCORDING TO THE CUSTOMER, THE NUMERICS START TO FLASH AND THEN SEEM TO RESET; HOWEVER, THE WAVEFORMS DISAPPEAR. THE ISSUE STARTED AFTER THE SOFTWARE WAS UPDATED TO VERSION 01-45 AND SUBSEQUENT DOWNGRADED BACK TO 01-40. THERE WAS NO PATIENT INJURY REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DATA FLICKERS ON THIS UNIT. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DATA FLICKERS ON THIS UNIT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795539 LIFE SCOPE G9 VITAL SIGNS MONITOR MHX NIHON KOHDEN CORPORATION CU-192R NA 04931921112168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BSM-1700.| BSM-1700.