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

Model Number GZ-120PA

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

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

Event Date 07/06/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the gz transmitter had shut down due to overheating and could not be turned back on until it had cooled down.No reports of patient harm.

Manufacturer Narrative

The biomedical engineer (bme) reported that the gz transmitter had shut down due to overheating and could not be turned back on until it had cooled down.No reports of patient harm.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 contain no information (ni), as an attempt to obtain information was made, but not provided: a2 - a6 b6 b7 attempt # 1: 07/07/2023 emailed the bme for the patient information and the concomitant medical device: the bme responded with the serial number for the cns, but the patient's information was unknown.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: 12/10/2017 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the gz transmitter had shut down due to overheating and could not be turned back on until it had cooled down.No reports of patient harm.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the gz transmitter had shut down due to overheating and could not be turned back on until it had cooled down.No reports of patient harm.Investigation summary: nihon kohden (nk) received the device on 07/28/2023.Nk repair center (rc) evaluated the unit on 09/13/2023.Nk rc could not duplicate the complaint as the unit would not turn on during evaluation.Nk rc inserted new batteries, and the unit would not turn on.They suspect the issue may be related to damage found near the rear enclosure, power board, and solder ball.Based on the device evaluation, the most likely cause is hardware component failure due to physical damage, which can occur through user mishandling.Since the device is designed to travel with the patient, it may be subject to excessive force from being dropped if it is not securely attached to the patient's bedside or clothing.General handling instructions are detailed in the operator's manual.Wear-and-tear may also be a contributing factor to the hardware failure as this depends on the device's age and frequency of use, and the complaint device has been in service for over 5 years.A review of the complaint device's serial number did not show other complaints.A review of the customer's complaint history for the gz transmitter did not reveal any trends for these issues.Nk will continue to monitor and trend similar complaints.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: 12/10/2017.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.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.H10 additional manufacturer narrative.

• Brand Name: GZ-120PA
• 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: 17443189
• MDR Text Key: 320228193
• Report Number: 8030229-2023-03689
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• 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: 11/01/2023

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
• Device Operator: 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: 07/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: CNS; CNS