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

Model Number GZ-130PA

Device Problem Overheating of Device (1437)

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

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the gz-130p transmitter was failing to communicate with the central nurse's station (cns) and the device was hot to touch.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 biomedical engineer reported that the gz-130p transmitter was failing to communicate with the central nurse's station (cns) and the device was hot to touch.

Event Description

The biomedical engineer reported that the gz-130p transmitter was failing to communicate with the central nurse's station (cns) and the device was hot to touch.

Manufacturer Narrative

Details of the complaint: on 03/27/19, gary lewis at (b)(6) hospital reported the vital sign telemeter (gz-130pa sn:(b)(6)) failed to communicate with the cns.The cns reported communication loss, and when the device was retrieved, it was hot to the touch.Service requested: warranty exchange.Service performed: the reported device was not returned.3 attempts were made to follow up with the customer, receiving no response.Investigation result: per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.The transmitter warranty began 12/30/2017 and the issue was reported after over 1 year at the customer facility.Review of device c4c history found one previously reported issue: notification (b)(4) (ticket (b)(4)) reported 03/24/2019 in which the unit was reported to have constant communication loss.This was found to have been caused by customer's it department in upgrading a network in the area.The device was not returned to nka and no nka evaluation could be performed.Due to the lack of customer response, further information is not available and the root cause is undetermined.The customer has not reported further issues with the unit.Review of complaints reported to nka found one additional case in which a gz transmitter was reported to get hot: notification 300178183 (ticket (b)(4)) reported 07/31/2019 at yavapai reg med ctr east.Evaluation of this unit is in progress.The total number of units sold between 2017-2019 for the gz-120 model is 761 and for the gz-130 model is 935.The complaint rate of 2 incidents reported for (b)(4) units is (b)(4).In both cases, there were no injuries or adverse patient events reported.Investigation conclusion: the device was not returned to nka and no nka evaluation could be performed.Due to the lack of customer response, further information is not available and the root cause is undetermined.The customer has not reported further issues with the unit.Additional information: h2.If follow-up, what type? additional information.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

• 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: 8520965
• MDR Text Key: 142626954
• Report Number: 8030229-2019-00099
• 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: 01/23/2020

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2020
• Distributor Facility Aware Date: 01/22/2020
• Device Age: 146 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2020
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 001
• Patient Sequence Number: 1