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

Model Number GZ-130PA

Device Problems Power Problem (3010); Complete Loss of Power (4015)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported the gz transmitter would spontaneously restart with no warning after about 20 minutes of operation.They tried new batteries, but the issue persisted.There were no signs of physical damage.The device was not in patient use at the time.The customer has requested an exchange.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.

Event Description

The customer reported the gz transmitter would spontaneously restart with no warning after about 20 minutes of operation.The device was not in patient use at the time.

Event Description

The customer reported the gz transmitter would spontaneously restart with no warning after about 20 minutes of operation.The device was not in patient use at the time.

Manufacturer Narrative

Details of complaint: the customer reported the gz transmitter would spontaneously restart with no warning after about 20 minutes of operation.They tried new batteries, but the issue persisted.There were no signs of physical damage.The device was not in patient use at the time.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.A similar issue was reported in ticket 172851 where the returned gz was evaluated.Nk repair center (rc) evaluated that device on 06/20/2023.Nihon kohden repair center (nk rc) duplicated the complaint and found that the ur-4301 circuit board had malfunctioned and there was a rattling noise inside the ecg connector of the rear case assembly.The cause of that issue was a hardware component failure likely due to physical damage and power issues from user mishandling or wear-and-tear.Physical damage occurs when excessive force is applied to the device such as when the device is dropped during transport or if the user attempts to plug cables into the wrong sockets.Power issues may occur through user mishandling or wear-and-tear.User mishandling may include insertion of batteries with the wrong orientation which can lead to a power surge, frying circuit board components such as the ur-4301.The possible root cause of the rebooting issue with gz-130pa (b)(6) is likely related to hardware failure.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15873458
• MDR Text Key: 307779100
• Report Number: 8030229-2022-03219
• 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: 12/27/2023

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-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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
• Treatment: NA.; NA.