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

Model Number GZ-130PA

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the gz transmitter was not alarming for a low battery.They stated that the gz did not beep, indicating it was going to be powering off.Biomed stated that the customer would like nihon kohden to review the logs.Not in patient use.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.D10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Attempt # 1: 05/12/2023 emailed the customer for concomitant medical device: no reply was received.Attempt # 2: 05/15/2023 emailed the customer for concomitant medical device: no reply was received.Attempt # 3: 05/16/2023 emailed the customer for concomitant medical device: no reply was received.

Event Description

The biomedical engineer reported that the gz transmitter did not alarm when the battery was low.Not in patient use.

• 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: 16947013
• MDR Text Key: 315406386
• Report Number: 8030229-2023-03561
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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