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

Model Number	GZ-120PA
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The onsite nihon kohden clinical application specialist reported that the transmitter was in patient use and started making buzzing sounds and getting a "room not registered" message.The transmitter and the batteries were extremely hot.No patient harm reported.The device will be exchanged.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.Concomitant medical products: the following device was being used in conjunction with the gz telemetry transmitter: central nurses station (cns).Model: pu-681ra sn 00482.
Event or Problem Description
The onsite nihon kohden clincal application specialist reported that the transmitter was in patient use and started making buzzing sounds and getting a "room not registered" message.The transmitter and the batteries were extremely hot.No patient harm reported.
Event or Problem Description
The onsite nihon kohden clincal application specialist reported that the transmitter was in patient use and started making buzzing sounds and getting a "room not registered" message.The transmitter and the batteries were extremely hot.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the onsite nihon kohden clinical application specialist reported that the transmitter was in patient use and started making buzzing sounds and receiving a "room not registered" message.The transmitter and the batteries were extremely hot.No patient harm was reported.The customer received an exchange to resolve the issue.Service requested / performed: exchange.Investigation summary: the issue of the gz overheating is most likely a result of improper battery installation by the user.Improper battery installation is known to cause overheating on transmitters.Nihon kohden repair center (nk rc) evaluated the reported device and found it to be in good working condition and was free of any physical damage.As the complaint could not be duplicated, root cause of this issue is most likely use error.A capa is not required per corrective action and preventive action process, sop07-003.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the transmitter: model #: pu-681ra; serial #: (b)(6).

• Brand Name: GZ-120PA
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 8936278
• Report Number: 8030229-2019-00405
• Device Sequence Number: 18986950
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022
• Report Date (Section F): 08/27/2019

1 Device was Involved in the Event

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-120PA
• Device Catalogue Number: GZ-120PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/31/2019
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2018
• 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: CNS PU-681RA; PU-681RA SN (B)(6)
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/27/2019