BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-530PA

    MDR report key: 9701993 · Received February 12, 2020

    Report

    Report Number
    8030229-2019-00579
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    September 6, 2019
    Report Date
    January 16, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921115091
    PMA / PMN Number
    K043517
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: ON (B)(6) 2019, CUSTOMER AT MERCY HEALTH PARTNERS REPORTED THAT WHOLE DEPARTMENT IN HUB ONE WENT INTO SIGNAL LOSS WITH ALL THE TRANSMITTER DEVICES ALONG WITH ZM-530PA FOR APPROXIMATELY 10-20 SECONDS. SERVICE REQUESTED: ASSISTANCE IN TROUBLESHOOTING SERVICE PERFORMED: CUSTOMER REPORTED THAT THE WHOLE DEPARTMENT WENT INTO SIGNAL LOSS FOR APPROXIMATELY 10-20 SECONDS. CUSTOMER HAS PROVIDED DEPARTMENT LOGS FOR REPORTING THE ISSUE, HOWEVER CUSTOMER WOULD NOT SHARE ANY ADDITIONAL INFORMATION. THE ROOT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED DUE TO LACK OF INFORMATION AS THE CUSTOMER REFUSE TO SHARE ANY RELATED INFORMATION TO THE ISSUE. INVESTIGATION CONCLUSION: THE ROOT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED DUE TO LACK OF INFORMATION AS THE CUSTOMER REFUSED TO SHARE ANY INFORMATION RELATED TO THE ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE WHOLE DEPARTMENT IN HUB ONE WENT INTO SIGNAL LOSS WITH ALL THE TRANSMITTER DEVICES FOR APPROXIMATELY 10 TO 20 SECONDS. NO CONSEQUENCE OR IMPACT TO THE PATIENTS WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE WHOLE DEPARTMENT IN HUB ONE WENT INTO SIGNAL LOSS WITH ALL THE TRANSMITTER DEVICES FOR APPROXIMATELY 10 TO 20 SECONDS. NO CONSEQUENCE OR IMPACT TO THE PATIENTS WAS REPORTED. THE CUSTOMER INDICATED THAT THEY WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION REGARDING THE EVENT. 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. BELOW IS THE EXACT DESCRIPTION OF THE CUSTOMER COMPLAINT: MONITORS LOSS CONNECTION IN HUB ONE FOR APPROXIMATELY 10-20 SECONDS AND THEN BACK ON. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: APPROXIMATE AGE OF DEVICE. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICES: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE TRANSMITTER IN THIS REPORT. TRANSMITTERS MODEL #: NI. SN #: NI. APPROXIMATE AGE OF THE DEVICE: NI (NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN.) DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. CENTRAL NURSE'S STATIONS (CNS) MODEL #: NI. SN #: NI. APPROXIMATE AGE OF THE DEVICE: NI (NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN.) DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. ORGS MODEL #: NI. SN #: NI. APPROXIMATE AGE OF THE DEVICE: NI (NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN.) DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WHOLE DEPARTMENT IN HUB ONE WENT INTO SIGNAL LOSS WITH ALL THE TRANSMITTER DEVICES FOR APPROXIMATELY 10 TO 20 SECONDS. NO CONSEQUENCE OR IMPACT TO THE PATIENTS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161657 ZM-530PA TRANSMITTER DRT NIHON KOHDEN CORPORATION ZM-530PA NA 04931921115091

    Patients

    Seq Age Sex Outcome Treatment
    1 TELEMETRY TRANSMITTERSCNS DEVICESORG DEVICES| TELEMETRY TRANSMITTERSCNS DEVICESORG DEVICES