BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 21925917 · Received April 29, 2025

    Report

    Report Number
    8030229-2025-04866
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    March 31, 2025
    Report Date
    May 8, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT A PAF ALARM WAS MISSED. ACCORDING TO THE CUSTOMER, THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM ON CONTINUOUS 13 BEATS. THE CUSTOMER IS PROVIDING THE LOGS FOR REVIEW. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: THE CUSTOMER COULD NOT PROVIDE THE NECESSARY INFORMATION TO PERFORM THE INVESTIGATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE CNS: ZM TRANSMITTER: MODEL #:ZM-530PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NO. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW UP, WHAT TYPE? H11 ADDITIONAL MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT A PAF ALARM WAS MISSED. ACCORDING TO THE CUSTOMER, THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM ON CONTINUOUS 13 BEATS. THE CUSTOMER IS PROVIDING THE LOGS FOR REVIEW. 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. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE CNS: ZM TRANSMITTER: MODEL #:ZM-530PA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NO.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PAF ALARM WAS MISSED. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PAF ALARM WAS MISSED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596196 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ZM-530PA| ZM-530PA