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

Model Number GZ-130PA

Device Problems Application Program Problem (2880); Unintended Application Program Shut Down (4032)

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the telemetry transmitter (tele) is constantly rebooting.They have already tried to troubleshooting the unit and was unable to resolve the issue.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.

Event Description

The biomedical engineer reported that the telemetry transmitter (tele) is constantly rebooting.They have already tried to troubleshooting the unit and was unable to resolve the issue.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer reported that the telemetry transmitter (tele) is constantly rebooting.They have already tried to troubleshooting the unit and was unable to resolve the issue.No patient harm was reported.Investigation conclusion: the complaint unit was returned and was evaluated.The device was not turning on.Nk repair center was unable to observe the constant reboot issue due to the device not turning on.The batteries of the device were replaced but the device would still not turn on.Nk repair center noted that the battery port has "heavy corrosion".The corrosion at the battery port is likely causing the constant reboot and power issues on the device.The corrosion on the battery port is likely caused by fluid intrusion.Residual moisture on the device could have dried up and had caused the corrosion of the battery port.Per operator's manual of the device, the device is waterproof but the battery case, electrode lead, and spo2 probe are not waterproof.

Event Description

The biomedical engineer reported that the telemetry transmitter (tele) is constantly rebooting.They have already tried to troubleshooting the unit and was unable to resolve the issue.No patient harm was reported.

• 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: 17801189
• MDR Text Key: 324765785
• Report Number: 8030229-2023-03769
• Device Sequence Number: 1
• Product Code: DRT
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION