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 05/16/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the nurses are telling him that the gz monitor is not alarming low battery at the cns.The bme states the nurses reported they never get an alarm and the batteries end up dying.This transmitter was being used as a regular gz and not being used in hi-q.No patient injury was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the nurses are telling him that the gz monitor is not alarming low battery at the cns.The bme states the nurses reported they never get an alarm and the batteries end up dying.This transmitter was being used as a regular gz and not being used in hi-q.No patient injury 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 not provided: a2 - a6.B6.B7.D10.Attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/12/2023 emailed the customer via microsoft outlook for patient information: no reply was received.

Event Description

The biomedical engineer (bme) reported that the nurses are telling him that the gz monitor is not alarming low battery at the cns.The bme states the nurses reported they never get an alarm and the batteries end up dying.This transmitter was being used as a regular gz and not being used in hi-q.No patient injury was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the nurses are telling him that the gz monitor is not alarming low battery at the cns.The bme states the nurses reported they never get an alarm and the batteries end up dying.This transmitter was being used as a regular gz and not being used in hi-q.No patient injury was reported.Investigation summary: the gz-130pa device was received to nihon kohden repair center (nkrc) on 06/14/2023.Nk repair center (rc) evaluated the device on 09/07/2023 and could not duplicate the complaint.The unit was tested per the operator's manual and administrator's guide but no problem was found.Review of the complaint device's serial number shows that it is over 1 year old and has no previous occurrence of this issue.An investigation was performed by nihon kohden corporation (nkc) which found that the device most likely shut down from power loss before it could generate communication of the low/weak battery status.This issue of 'no alarm for low battery' for this customer was investigated by nkc which confirmed that the customer is using batteries not recommended for use with the gz transmitter.From review of device logs from similar reported complaints for this customer nkc found that the device most likely shut down from power loss before it could generate communication of the low/weak battery status.The gz operator's manual recommends using medipower alkaline batteries or panasonic nimh batteries.Nk field support engineer/account manager reported that the customer has switched from using procell constant to procell intense batteries.This will continue to be monitored by nk.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 d10 attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/12/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Additional information: e1 initial reporter information.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h10 additional manufacturer narrative.Correction to investigation summary.Manufacturer references# (b)(4) follow up 002.

Event Description

The biomedical engineer (bme) reported that the nurses are telling him that the gz monitor is not alarming low battery at the cns.The bme states the nurses reported they never get an alarm and the batteries end up dying.This transmitter was being used as a regular gz and not being used in hi-q.No patient injury was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the nurses are telling him that the gz monitor is not alarming low battery at the cns.The bme states the nurses reported they never get an alarm and the batteries end up dying.This transmitter was being used as a regular gz and not being used in hi-q.No patient injury was reported.Investigation summary: the gz-130pa device was received to nihon kohden repair center (nkrc) on 06/14/2023.Nk repair center (rc) evaluated the device on 09/07/2023 and could not duplicate the complaint.The unit was tested per the operator's manual and administrator's guide but no problem was found.Review of the complaint device's serial number shows that it is over 1 year old and has no previous occurrence of this issue.An investigation was performed by nihon kohden corporation (nkc) which found that the device most likely shut down from power loss before it could generate communication of the low/weak battery status.This issue of 'no alarm for low battery' for this customer was investigated by nkc which confirmed that the customer is using batteries not recommended for use with the gz transmitter.From review of device logs from similar reported complaints for this customer nkc found that the device most likely shut down from power loss before it could generate communication of the low/weak battery status.The gz operator's manual recommends using medipower alkaline batteries or panasonic nimh batteries.Nk field support engineer/account manager reported that the customer has switched from using procell constant to procell intense batteries.The customer's complaint history shows that recurrence of this issue for the gz transmitter has not been reported since investigation was closed.This will continue to be monitored by nk.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 d10 attempt # 1: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/12/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Additional information: b4 date of this report d9 device available for evaluation? g3 date received by manufacturer g6 type of report h2 if follow up, what type? h3 device evaluated by manufacturer? h6 adverse event codes h10 additional manufacturer narrative manufacturer references# (b)(4)follow up 001.

• 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: 17110691
• MDR Text Key: 317780331
• Report Number: 8030229-2023-03582
• 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,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• 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.; CNS.