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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the gz transmitter was powering on and off unexpectedly.They tried new batteries, but the issue persisted.There were no signs of physical damage or fluid intrusion.There was no patient harm reported.They sent the unit in for 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.Additional device information: concomitant medical device: the following device(s) was used in conjunction with the gz transmitter:.Cns:.Model #: ni.Serial #: ni.

Event Description

The customer reported that the gz transmitter was powering on and off unexpectedly.

Event Description

The customer reported that the gz transmitter was powering on and off unexpectedly.

Manufacturer Narrative

Details of complaint: the customer reported that the gz transmitter was powering on and off unexpectedly.They tried new batteries, but the issue persisted.There were no signs of physical damage or fluid intrusion.No patient harm or injury was reported.Investigation summary: the issue persisted even with new batteries.The complaint device was returned by the customer and an evaluation was performed by nihon kohden repair center (nk rc).The device was not powering on.Nk rc indicated there was some rattling inside the unit.The rattling inside the unit suggests physical damage and with a loose component inside the device.This may be caused by device mishandling, device drop, or strong impacts to the device.The reported issue is likely due to physical damage to the device.A review of the history of the serial number identified no other reports on the device.There is no significant trend identified regarding the reported issue.

• 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: 16260098
• MDR Text Key: 308655841
• Report Number: 8030229-2023-03290
• 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: 05/19/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• 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