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

Model Number GZ-130PA

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that patient info is being dropped off of the screen of their gz-130pa telemetry devices.The devices go back to the admit screen and all of the patient information is gone.The nihon kohden networking team is checking the telemetry server.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 if additional information becomes available.

Event Description

The customer reported that patient info is being dropped off of the screen of their gz-130pa telemetry devices.The devices go back to the admit screen and all of the patient information is gone.

Manufacturer Narrative

Details of the complaint on (b)(6) 2018, customer at (b)(6) health system reported losing patient information on the new gz (gz-130pa) system.The technicians noticed that sometimes, the patients would drop off the screen and upon going back to the admit screen, all the patient information was lost.This was occurring across all floors that the gz transmitters were installed on.Service requested: customer wanted to report the issue as they are one of nka's test sites.Service performed: 3 attempts were made to follow up with the customer, receiving no response.Investigation result: extent of troubleshooting performed for the issue is not provided.Due to the lack of customer response, information is limited and the root cause could not be determined.Review of tickets opened at st.Francis health system found no additional issues relating to patient information being dropped or lost at around the reported date.Investigation conclusion: due to the lack of customer response, information is limited and the root cause could not be determined.Review of tickets opened at st.Francis health system found no additional issues relating to patient information being dropped or lost at around the reported date.

Event Description

The customer reported that patient info is being dropped off of the screen of their gz-130pa telemetry devices.The devices go back to the admit screen and all of the patient information is gone.

• Brand Name: GZ-130PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 7382436
• MDR Text Key: 103924368
• Report Number: 8030229-2018-00094
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• Combination Product (y/n): N
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• 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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2020
• Distributor Facility Aware Date: 01/06/2020
• Device Age: 0 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2020
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1