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 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter (tele) gets hot.The unit is not able to hold on to the battery power, and they need to replace the batteries often.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.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6; b6 - b7; d10 concomitant medical device.Attempt #1, 05/22/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2, 05/30/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3, 06/14/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they were not able to provide the patient and additional device information.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter (tele) gets hot.The unit is not able to hold on to the battery power, and they need to replace the batteries often.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter (tele) gets hot.The unit is not able to hold on to the battery power, and they need to replace the batteries often.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the telemetry transmitter (tele) gets hot.The unit is not able to hold on to the battery power, and they need to replace the batteries often.No patient harm was reported.Investigation conclusion: multiple requests for information regarding the return of the complaint device were sent to the customer, but they have been unresponsive.A definitive root cause for the overheating and power hold issues could not be determined since we could not duplicate the complaint due to the device not being returned for evaluation.Possible causes of both issues are likely related to hardware component failure which can occur through physical damage, fluid intrusion, power issues, or wear-and-tear.Physical damage and fluid intrusion can occur through user mishandling.Since the device is designed to be mobile there is a possibility for it to be dropped on hard surfaces or fluids.The device is neither shockproof nor waterproof.The operator's manual includes instructions on how to securely attach the transmitter to the patient's clothing or bedside.Power issues may arise from user errors such as inserting batteries in the incorrect orientation or using batteries not specified for use with the device.Power requirements and battery insertion instructions are listed in the operator's manual.Inserting batteries in the wrong orientation will cause a short-circuit which can lead to heat between the battery springs and batteries.The operator's manual also states to check the charge on the batteries before use.Old batteries may have leaks and deteriorated insulation which can lead to short-circuits if used.Wear-and-tear of hardware components depends on device age and frequency of use.Review of the complaint device's serial number shows that the device is over 1 year old and has no other complaints.Review of the customer's complaint history from the past two years shows 1 previous similar complaint under ticket 137431 (300290548) in which it was reported that the transmitter battery cover got warm, and the issue was resolved after swapping to new batteries.

• 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: 17132160
• MDR Text Key: 317779230
• Report Number: 8030229-2023-03576
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• 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: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2021
• 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