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

Model Number GZ-130PA

Device Problems No Audible Alarm (1019); Protective Measures Problem (3015)

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

Event Date 12/06/2023

Event Type  Death  

Manufacturer Narrative

The customer reported that a patient passed away while on this gz transmitter and the staff claims that there were no alarms.The customer believes that the battery ran out on the unit while the patient was in the shower and the staff was unaware when they put the device back on the patient to monitor after.The customer is not sure if the unit was in monitor mode at the time of the incident.The customer does not believe that the device is at fault.The customer could not provide the central nurse's station (cns) information; however, the customer collected the logs from the transmitter.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 attempt # 1: 12/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 12/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 12/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 12/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 12/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 12/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 12/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 12/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 12/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns:.

Event Description

The customer reported that a patient passed away while on this gz transmitter and the staff claims that there were no alarms.

• 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: 18432662
• MDR Text Key: 331767276
• Report Number: 8030229-2024-03964
• 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
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• 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: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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: CNS
• Patient Outcome(s): Death