MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120P; TRANSMITTER

Model Number	GZ-120P
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer reported that after it was removed from the patient and when going to turn it off, the nurses noticed that the device was very hot.Therefore, they left it on the counter to cool down.The nurses reported that the battery was very swollen and that the battery acid eventually began leaking out onto the gz telemetry transmitter.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer reported that after it was removed from the patient and when going to turn it off, the nurses noticed that the device was very hot.Therefore, they left it on the counter to cool down.The nurses reported that the battery was very swollen and that the battery acid eventually began leaking out onto the gz telemetry transmitter.No patient harm was 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.Attempt #1 (b)(6) 2022, emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2022, emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient and device information as requested.
Event or Problem Description
The biomedical engineer (bme) reported that after the gz telemetry transmitter was removed from the patient, the device was very hot.The battery was found to be swollen and leaking battery acid into the transmitter.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that after the gz telemetry transmitter was removed from the patient, the device was very hot.The battery was found to be swollen and leaking battery acid into the transmitter.No harm or injury was reported.Investigation summary: the reported device was sent in for an exchange.During the evaluation of the returned device nihon kohden repair center (nk rc) found that the device was physically damaged with traces of battery corrosion.As such, the cause of the battery acid leaking from the device is likely related to physical damage.Physical damage is likely to occur as a result of mishandling or wear and tear.Mishandling of a device can be related to dropping the device, hard impacts, or improper use.Damage to the device can extend to internal components vital for operation.In this case, the damage may have extended to the battery itself and caused a leakage of battery acid.An overall complaint review does not show similar complaints.The following fields contains no information (ni), as attempts to obtain the information were made, but not provided.A2 - a6 b6 - b7 d10 attempt #1: 11/29/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 12/02/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details, but did not provide the requested information.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.
Additional Manufacturer Narrative
**udi related data quality updates** corrected information: d1 brand name: corrected the brand name from gz-120pa to gz-120p.D2b product code: corrected the product code from drt to mhx.D4 additional device information / model #: corrected the model # from gz-120pa to gz-120p.D4 additional device information / catalog #: corrected the catalog # from gz-120pa to gz-120p.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.Additional information: b4 data of this report g6 type of report h2 if follow up, what type?.
Event or Problem Description
The biomedical engineer (bme) reported that after the gz telemetry transmitter was removed from the patient, the device was very hot.The battery was found to be swollen and leaking battery acid into the transmitter.No patient harm was reported.

• Brand Name: GZ-120P
• Common Device Name: 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: 16000834
• Report Number: 8030229-2022-03231
• Device Sequence Number: 17784564
• Product Code: MHX
• UDI-Device Identifier: 04931921117392
• UDI-Public: (01)04931921117392(21)1209
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GZ-120P
• Device Catalogue Number: GZ-120P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/01/2023; 12/01/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 12/04/2023; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.; NI.
• Patient Sex: Unknown