BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 9162078 · Received October 7, 2019

    Report

    Report Number
    8030229-2019-00539
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 11, 2019
    Report Date
    December 19, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: ON (B)(6) 2019, CUSTOMER AT MEDICAL CENTER @ (B)(6) REPORTED INTERMITTENT SIGNAL LOSS WITH 4 GZ-130PA UNITS. THE AFFECTED UNITS WERE LOCATED ON THE 5TH FLOOR AND OUTAGES WERE ONE MINUTE OR LESS IN LENGTH, WITH OCCURRENCES BETWEEN 10 MINUTES TO 2 HOURS APART. THE GZ UNITS WERE 10 STEPS AWAY FROM THE ACCESS POINT (NK PROVIDED CISCO AP-2802I). THE DEVICE LISTED IN THE COMPLAINT RECORD IS VITAL SIGN TELEMETER (GZ-130PA SN: (B)(6)). INFORMATION ON THE ADDITIONAL 3 GZ UNITS EXPERIENCING THE ISSUE WAS NOT PROVIDED. SERVICE REQUESTED : TROUBLESHOOTING/ASSISTANCE . SERVICE PERFORMED : ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER, RECEIVING NO FURTHER INFORMATION. INVESTIGATION RESULT : TRENDING OF TICKETS OPENED AT MEDICAL CENTER @ BOWLING GREEN FOUND THE FOLLOWING ISSUES REPORTED RELATING TO NETWORK: ID CREATED ON PRODUCT ID DESCRIPTION. 46948, (B)(6) 2018, 06:12 AM, GZ-130PA NETWORK COMMUNICATION. 47968, (B)(6) 2019, 06:41 AM, GZ-130PA NETWORK COMMUNICATION. 67935, (B)(6) 2019, 06:28 AM, GZ-130PA NETWORK OUTAGE. 72902, (B)(6) 2019, 08:00 AM, GZ-130PA TRANSMITTER KEEPS DROPPING OFF NETWORK DUE TO THE LACK OF CUSTOMER RESPONSE, INFORMATION IS LIMITED AND THE ROOT CAUSE COULD NOT BE DETERMINED. INVESTIGATION CONCLUSION DUE TO THE LACK OF CUSTOMER RESPONSE, INFORMATION IS LIMITED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE BUT NOT PROVIDED: F9 APPROXIMATE AGE OF THE DEVICE. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. G5 PMA/510(K) NUMBER. H4 DEVICE MANUFACTURER DATE. ADDITIONAL MODEL INFORMATION: D11 & C2: THE FALLOWING TRANSMITTERS WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN SOME OF THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: TRANSMITTER. MODEL: GZ-130PA. S/N: (B)(6) . APPROXIMATE AGE OF THE DEVICE: 01/30/2017. DEVICE MANUFACTURER DATE: 32 MONTHS. UNIQUE IDENTIFIER (UDI) #: (B)(4). TRANSMITTER: MODEL: GZ-130PA. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: (B)(4). TRANSMITTER: MODEL: GZ-130PA. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: (B)(4). TRANSMITTER: MODEL: GZ-130PA. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS EXPERIENCING INTERMITTENT SIGNAL LOSS WITH 4 TRANSMITTERS.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS EXPERIENCING INTERMITTENT SIGNAL LOSS WITH 4 TRANSMITTERS. THE AFFECTED TRANSMITTERS ARE LOCATED ON THE 5TH FLOOR OF THE HOSPITAL'S C WING, ROOMS 9-12. ALL 4 DEVICES ARE STATIONED ABOUT 10 STEPS AWAY FROM THE NIHON KOHDEN PROVIDED ACCESS POINT (CISCO AP-2802I). THE OUTAGES WERE A MINUTE OR LESS IN DURATION, WHILE THE INSTANCES WERE BETWEEN 10 MINUTES TO 2 HOURS APART. NO PATIENT HARM OR INJURY WAS REPORTED. NIHON KOHDEN'S TECHNICAL SERVICES IS CURRENTLY WORKING ON RESOLVING THIS ISSUE. 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. APPROXIMATE AGE OF THE DEVICE. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. ADDITIONAL MODEL INFORMATION: THE FOLLOWING TRANSMITTERS WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN SOME OF THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: TRANSMITTER MODEL: GZ-130PA, S/N: (B)(4), APPROXIMATE AGE OF THE DEVICE: 01/30/2017, DEVICE MANUFACTURER DATE: 32 MONTHS, UNIQUE IDENTIFIER (UDI) #: (B)(4). TRANSMITTER, MODEL: GZ-130PA, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: (B)(4). TRANSMITTER , MODEL: GZ-130PA, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: (B)(4). TRANSMITTER, MODEL: GZ-130PA, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS EXPERIENCING INTERMITTENT SIGNAL LOSS WITH 4 TRANSMITTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956098 NI CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization 4 TRANSMITTERS| 4 TRANSMITTERS