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

Model Number GZ-130PA

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Protective Measures Problem (3015)

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

Event Date 06/22/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that on 06/22/2023 at 08:31-08:33 the gz transmitter was powered off but he cannot confirm if the battery died or the staff removed the batteries.The bme wanted to know why they did not get a notification for a change transmitter battery and will send in the event logs for this issue to nihon kohden.The bme stated the gz transmitter was in hi-q connected to a g9 bedside monitor while in use with a patient.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that on 06/22/2023 at 08:31-08:33 the gz transmitter was powered off but he cannot confirm if the battery died or if the staff removed the batteries.The bme wanted to know why they did not get a notification for a change transmitter battery and will send in the event logs for this issue to nihon kohden.The bme stated the gz transmitter was in hi-q connected to a g9 bedside monitor while in use with a patient.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.The following field(s) contain no information (ni), as attempts to obtain information were made, but could not be provided: a2 - a6 - unk, b6 - unk, b7 - unk.Attempt # 1: 06/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: reply was received from the biomed who stated this is data that the biomedical engineer cannot provide.Additional device information: d10 concomitant medical device: the following device(s) was used in conjunction with the gz transmitter: cns: model #: pu-681, serial #: (b)(6), device manufacturer data: 10/04/2020 unique identifier (udi) #: (b)(4).Model #: cu-192ra, serial #: (b)(4), device manufacturer data: 09/04/2020, unique identifier (udi) #: (b)(4).

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that on (b)(6) 2023 at 08:31-08:33 the gz transmitter was powered off, but he cannot confirm if the battery died or if the staff removed the batteries.The bme wanted to know why they did not get a notification for a change transmitter battery and will send in the event logs for this issue to nihon kohden.The bme stated the gz transmitter was in hi-q connected to a g9 bedside monitor while in use with a patient.No patient harm was reported.Investigation summary: no device was returned to nihon kohden for inspection.Investigation of the reported issue concludes that the two probable causes for no alarm for low battery are related to use of unspecified batteries.The batteries recommended in the operator's manual of the gz-130p are the only batteries that were verified to operate well with the device.The internal resistance of the battery will determine how well it operates with the gz-130p and it cannot be determined with battery specifications alone.Root cause has been identified as the use of non-specified batteries.Root cause has been identified as the use of non-specified batteries.There is no evidence of an nk device malfunction that may have contributed to the reported issue.The customer had changed the type of batteries used to resolve the issue.The following field(s) contain no information (ni), as attempts to obtain information were made, but could not be provided: a2 - a6 - unk b6 - unk b7 - unk attempt # 1: 06/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 07/12/2023 emailed the customer via microsoft outlook for patient information: reply was received from the biomed who stated that this is data that the biomedical engineer cannot provide.Additional device information: d10 concomitant medical device: the following device(s) was used in conjunction with the gz transmitter: cns: model #: pu-681 serial #: (b)(6) device manufacturer data: 10/04/2020 unique identifier (udi) #: (b)(4) model #: cu-192ra serial #: (b)(6) device manufacturer data: 09/04/2020 unique identifier (udi) #: (b)(4) additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow - up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that on (b)(6) 2023 at 08:31-08:33 the gz transmitter was powered off but he cannot confirm if the battery died or the staff removed the batteries.The bme wanted to know why they did not get a notification for a change transmitter battery and will send in the event logs for this issue to nihon kohden.The bme stated the gz transmitter was in hi-q connected to a g9 bedside monitor while in use with a patient.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: 17329705
• MDR Text Key: 319496175
• Report Number: 8030229-2023-03670
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• 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: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2020
• 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: BEDSIDE MONITOR; BEDSIDE MONITOR; CNS; CNS