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

Model Number GZ-130PA

Device Problem Intermittent Communication Failure (4038)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the transmitter (gz) randomly turned off anytime it was moved around too much.They replaced the batteries, but the issue persisted.There were 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 attempts to obtain information were made, but not provided: a2 - a6.B6 - b7.Attempt # 1: 10/30/2023 emailed the bme for the patient information.The bme replied, "not available." additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: (b)(4).Model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 12/04/2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the transmitter (gz) randomly turned off anytime it was moved around too much.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the transmitter (gz) randomly turned off anytime it was moved around too much.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the transmitter (gz) randomly turned off anytime it was moved around too much.They replaced the batteries, but the issue persisted.There were no reports of patient harm.Investigation summary: nihon kohden (nk) received the complaint device on 11/08/2023.Nk repair center (rc) evaluated the device on 02/06/2024 and could not duplicate the complaint; however, multiple issues were found.The unit was tested with new batteries.The touch screen was unresponsive and stuck on "admit patient.' there was a rattling sound from inside the unit, and corrosion was found on the battery contacts.The ecg and spo2 ports were dirty.Although we could not duplicate the complaint, the cause is likely hardware component failure due to physical damage, which can come from user mishandling or wear-and-tear.A review of the complaint device's serial number shows that the unit is six years old and has no other complaints.Due to the device's age, wear-and-tear may likely contribute to the hardware failure.A review of the customer's complaint history did not show any trends for this issue and device.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-6801a model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 12/04/2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

• 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: 18207423
• MDR Text Key: 328945526
• Report Number: 8030229-2023-03898
• 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: 02/12/2024

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: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/24/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2017
• 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