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

Model Number GZ-130PA

Device Problems Power Problem (3010); Intermittent Loss of Power (4016)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the gz transmitter experienced spontaneous and intermittent shutdowns.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the gz transmitter experienced spontaneous and intermittent shutdowns.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.Attempt # 1: 06/08/2023 emailed the bme for patient information and the concomitant medical device: no reply was received.Attempt # 2: 06/12/2023 emailed the bme for patient information and the concomitant medical device: no reply was received.Attempt #3: 06/15/2023 emailed the bme for patient information and the concomitant medical device: no reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the gz transmitter experienced spontaneous and intermittent shutdowns.No patient harm was reported.Investigation summary: nihon kohden (nk) received the complaint device on 07/14/2023.Nk repair center (nk rc) evaluated the unit on 09/25/2023 and could not duplicate the complaint.Nk rc observed intermittent communication loss during testing.A definitive root cause could not be determined since the complaint could not be duplicated during evaluation.Possible causes of the spontaneous shutdowns may include user error with battery usage or hardware component failure.Examples of user error with battery usage include using batteries that are not fully charged or incorrect insertion.Hardware component failure can occur through physical damage or fluid intrusion from user mishandling, power issues from improper battery insertion, which can lead to short-circuits, or wear-and-tear, which depends on device age and frequency of use.The intermittent communication loss observed during evaluation may be due to momentary electromagnetic interference from nearby devices or hardware component issues.Review of the device's serial number shows that it is 4 years old and has no other complaints.It was documented that the customer has recently switched to using a different battery.Nk will continue to monitor this issue and trend similar complaints.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.B6.B7.D10.Attempt # 1: 06/08/2023, emailed the bme for all items under the no information list.No reply was received.Attempt # 2: 06/12/2023, emailed the bme for all items under the no information list.No reply was received.Attempt #3: 06/15/2023, emailed the bme for all items under the no information list.No reply was received.Additional device information: 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: na.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 event problem and evaluation codes.H10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the gz transmitter experienced spontaneous and intermittent shutdowns.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: 17205217
• MDR Text Key: 318238274
• Report Number: 8030229-2023-03608
• 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: 09/27/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2018
• 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