MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120PA; TRANSMITTER

Model Number GZ-120PA

Device Problem Battery Problem (2885)

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

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their gz transmitter is overheating when in monitor mode.The failed device will be sent in for an evaluation.No patient harm or injury 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: concomitant medical products.

Event Description

The customer reported that their gz transmitter is overheating when in monitor mode.

Manufacturer Narrative

Details of complaint: on (b)(6) 2020, customer reported that gz-120pa s/n: (b)(6) was overheating when in monitoring mode.Customer did not provide additional details.Nk tech support requested device and batteries to be sent to nka for evaluation.After a few attempts, customer sent device in on (b)(6) 2020 but without the batteries used during the reported incident.Investigation summary: due to limited information and evidence provided by customer, the root cause of the reported overheating issue could not be determined.Based on the low risk profile and risk mitigating factors inherent in the design, further action is not warranted at this time.D4: lot# & expiration date.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: d11 & c2 concomitant medical products.Additional information: b4.Date of this report.D10 device availability.F6.Date user facility/ importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.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 customer reported that their gz transmitter is overheating when in monitor mode.

• Brand Name: GZ-120PA
• 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: 9903647
• MDR Text Key: 200797882
• Report Number: 8030229-2020-00193
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• Combination Product (y/n): N
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

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-120PA
• Device Catalogue Number: GZ-120PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2020
• Distributor Facility Aware Date: 06/11/2020
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1