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

Model Number GZ-130PA

Device Problems Power Problem (3010); Complete Loss of Power (4015)

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

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the nurses are stating that the gz telemetry transmitter is not alarming low battery at the central nurse's station (cns).They stated that they never get an alarm, and the batteries end up dying.This transmitter was being used as a gz telemetry transmitter and not being used in hi-q view.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 fields are not applicable (na) to the mdr report: b2 d4 lot number & expiration d6a - d6b d7b f1 - f14 g4 device bla number g5 g7 h2 h7 h9 the following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6 b6 - b7 d10 concomitant medical device attempt #1 05/17/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 05/30/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 06/13/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station model: ni sn: ni.

Event Description

The biomedical engineer (bme) reported that the nurses are stating that the gz telemetry transmitter is not alarming low battery at the central nurse's station (cns).They stated that they never get an alarm, and the batteries end up dying.This transmitter was being used as a gz telemetry transmitter and not being used in hi-q view.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the nurses are stating that the gz telemetry transmitter is not alarming low battery at the central nurse's station (cns).They stated that they never get an alarm, and the batteries end up dying.This transmitter was being used as a gz telemetry transmitter and not being used in hi-q view.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the nurses are stating that the gz telemetry transmitter is not alarming low battery at the central nurse's station (cns).They stated that they never get an alarm, and the batteries end up dying.This transmitter was being used as a gz telemetry transmitter and not being used in hi-q view.No patient harm was reported.Service performed and investigation conclusion: nihon kohden received the device on 06/13/2023.Nihon kohden repair center evaluated the unit on 06/22/2023 and could not duplicate the complaint.The unit was evaluated again on 08/28/2023 and the complaint could not be duplicated, however, rc also found a rattling noise coming from inside the unit.It is unclear if the ratting noise is related to the issue.Review of the complaint device's serial number shows that it is 2 years old and has no other complaints.A definitive root cause for the battery alarm issue could not be determined since the complaint could not be duplicated; however, based on review of similar complaints from the customer, possible cause is likely related to the type of battery that the customer was using at the time.Review of the customer's complaint history shows several similar complaints under the following tickets: (b)(4).This issue of 'no alarm for low battery' for this customer was investigated by nihon kohden corporation (nkc) which concluded on (b)(6) 2023.The issue was confirmed through device logs from ticket 167001 and found to be due to the customer using batteries not recommended for use with the gz transmitter.From the device logs, 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 fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.Attempt #1 05/17/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 05/30/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 06/13/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station model: ni sn: ni.

• 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: 17122628
• MDR Text Key: 317544466
• Report Number: 8030229-2023-03574
• 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,Followup
• Report Date: 09/12/2023

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: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• 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: CENTRAL NURSE'S STATION.; CENTRAL NURSE'S STATION.