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

Model Number GZ-130PA

Device Problems No Audible Alarm (1019); Battery Problem (2885); Communication or Transmission Problem (2896)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this transmitter and others are sporadically going into communication loss (comm loss) due to battery issues.According to the customer, the unit is not alarming for the low battery issue, it will just go into comm loss at the central nurse's station (cns).When they check on the device, they notice that the batteries are dead.There was no patient injury 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 contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/17/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have specific patient information.B6.Attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/17/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have specific patient information.B7.Attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/17/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have specific patient information.D10.Attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 05/17/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i don't have specific patient information.

Event Description

The customer reported that this transmitter and others are sporadically going into communication loss (comm loss) due to battery issues.There was no patient injury reported.

Event Description

The customer reported that this transmitter and others are sporadically going into communication loss (comm loss) due to battery issues.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this transmitter and others are sporadically going into communication loss (comm loss) due to battery issues.According to the customer, the unit is not alarming for the low battery issue, it will just go into comm loss at the central nurse's station (cns).When they check on the device, they notice that the batteries are dead.There was no patient injury reported.Investigation summary: the nihon kohden (nk) field support engineer/account manager reported on 08/02/2023 that the issue has been remediated since the customer switched from using procell constant to procell intense batteries.Review of the complaint device's serial number shows that it has been in service for 1 year and has no other complaints.Review of the customer's complaint history shows several similar complaints under the following tickets: 167001, 167002, 173465, 173467, 174749, 174871, 176609, 177366, 179347.This issue of "no alarm for low battery" for this customer was investigated and confirmed through the device's logs from ticket 167001 and found to be due to the customer using batteries not recommended for use with the gz transmitter.The gz operator's manual recommends using medipower alkaline batteries or panasonic nimh batteries.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/17/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have specific patient information.Attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/17/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have specific patient information.Attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/17/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have specific patient information.Attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 05/17/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i don't have specific patient information.Additional information: date of this report date received by manufacturer type of report if follow up, what type? additional manufacturer narrative manufacturer references # 300331125 - 172929 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: 17061006
• MDR Text Key: 317660332
• Report Number: 8030229-2023-03554
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• 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: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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; CNS