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

Model Number GZ-130PA

Device Problems Application Network Problem (2879); Appropriate Term/Code Not Available (3191); Patient Data Problem (3197)

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

Event Date 08/21/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter was switching from one tile to another and discharge the patient by itself.It appears that the unit may have powered off due to the batteries being low.The customer will collect the central nurse's station (cns) logs.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.(b)(6).Additional model information: concomitant medical device: the following device was used in conjunction with the transmitter: cns: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.

Event Description

The customer reported that the transmitter was switching from one tile to another and discharge the patient by itself.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter was switching from one tile to another and discharged the patient on its own.No patient harm was reported.Investigation summary: the device logs were sent in for analysis.However, the log analysis could not be performed for the cns because the customer did not provide the necessary information needed.The customer stated they would call in with the requested information but did not do so.As the log analysis of the connected cns could not take place, a root cause could not be determined.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.The root cause may be related to the hospital's network environment or network configuration of the gz, such as improper ip configuration or a duplicate ip.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: cns: model#: ni, serial#: ni, (h4) device manufacturer date: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.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 customer reported that the transmitter was switching from one tile to another and discharged the patient on its own.There was no patient injury 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12497628
• MDR Text Key: 272234921
• Report Number: 8030229-2021-01688
• 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: 09/05/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• 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.; CNS