MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-130PA; TRANSMITTER

Model Number GZ-130PA

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2022

Event Type  malfunction  

Event Description

The customer reported that they were missing about an hour of data when this gz went into sleep mode while monitoring a patient.No harm or injury occurred.The central nurse's station (cns) did not display communication loss during this time as it was displaying live data.

Manufacturer Narrative

The customer reported that they were missing about an hour of data when this gz went into sleep mode while monitoring a patient.No harm or injury occurred.The central nurse's station (cns) did not display communication loss during this time as it was displaying live data.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: concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: model #: pu-681ra.Serial #: (b)(4).Device manufacturer data: 04/14/2020.Unique identifier (udi) #: (b)(4).

Manufacturer Narrative

Details of complaint: the customer reported that while monitoring a patient the gz transmitter went into sleep mode and was missing about an hour of data.There was no comm loss error displayed at the central nurse's station (cns).No patient harm was reported.Investigation summary: the device logs from the cns and the gz transmitter were sent in for analysis.Evaluation of the gz and cns logs revealed that the gz was in communication loss with the cns at the time.No abnormalities were found with the cns and the gz logs.As no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal similar complaints.Nkc recommends replacement of the gz should the issue recur.It is likely that the gz may have had hardware failure.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.The gz was installed in (b)(6) 2021.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 04/14/2020.Unique identifier (udi) #: (b)(4).

Event Description

The customer reported that while monitoring a patient the gz transmitter went into sleep mode and was missing about an hour of data.There was no comm loss error displayed at the central nurse's station (cns).No patient harm was reported.

• Brand Name: GZ-130PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13862531
• MDR Text Key: 289023671
• Report Number: 8030229-2022-02665
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GZ-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CNS; CNS