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

Model Number GZ-130PA

Device Problems Overheating of Device (1437); Temperature Problem (3022)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the gz telemetry transmitter is experiencing overheating.The bme tried to change settings in attempt to lower temperature or tried changing batteries.However, the problem still persists.It is unknown if the device was in patient use.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.The following fields are not applicable (na) to the mdr report: a2 - a6.B6 - b7.D4 lot number & expiration.D6a - d6b.D10 concomitant medical device.F1 - f14.G4 device bla number.

Event Description

The biomedical engineer (bme) reported that the gz telemetry transmitter is experiencing overheating.The bme tried to change settings in attempt to lower temperature or tried changing batteries.However, the problem still persists.It is unknown if the device was in patient use.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the gz telemetry transmitter overheated.The bme tried changing the batteries and the settings in attempt to lower the temperature, but the issue persisted.It was unknown if the device was in patient use.Investigation summary: a definitive root cause could not be identified due to the lack of response from the customer.Without the root cause, countermeasures to prevent recurrence of the issue could not be implemented.Nk will continue to trend and monitor the reported issue.No corrective actions will be performed at this time.

Event Description

The biomedical engineer (bme) reported that the gz telemetry transmitter overheated.The bme tried changing the batteries and the settings in attempt to lower the temperature, but the issue persisted.It was unknown if the device was in patient use.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17509919
• MDR Text Key: 321056155
• Report Number: 8030229-2023-03692
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2017
• 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: NI.; NI.