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

Model Number GZ-130PA

Device Problem Communication or Transmission Problem (2896)

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

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their vital sign telemetry is experiencing continuous dropouts from the network.No harm or injury was reported.The customer will be sending this particular unit in for an exchange.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.The following fields contains no information (ni), as attempts to obtain information were made, but not provided.Patient information.

Event Description

The customer reported that their vital sign telemetry is experiencing continuous dropouts from the network.

Manufacturer Narrative

Details of complaint: the customer reported that the vital sign telemetry was experiencing continuous dropouts from the network.No patient harm or injury was reported.Investigation summary: nihon kohden technical support (nk ts) initiated an exchange.With the available information, a root cause cannot be determined.Device received into nk warehouse.The exchange unit was installed, and the issue was resolved.Comm loss is an error message displayed on individual bed tiles on the cns that alerts clinicians that the connection between the cns and the device it is monitoring has been lost.Potential causes of comm loss: network issues: the access points in the area where the issue is occurring may have been loaded with traffic or have a bad connection, or they may have experienced interference in the area causing the connectivity issues.If the network host table becomes unbalanced, comm loss could occur.If the telemetry device is approaching the range boundaries or out of range of an access point, it may experience comm loss.

Event Description

The customer reported that the vital sign telemetry was experiencing continuous dropouts from the network.

• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10574364
• MDR Text Key: 208159270
• Report Number: 8030229-2020-00662
• 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
• Report Date: 03/02/2023

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: 09/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2017
• 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: NA.