MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION WEP-4208A; TELEMETRY MONITORING SYSTEM

Model Number	WEP-4208A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that they experienced telemetry signal noise intermittently on multiple channels on their loaner telemetry system (wep) device.After some troubleshooting, it was determined that this was not the result of interference and that the wep loaner device will need to be exchanged due to the failure of that device.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.
Event or Problem Description
The customer reported that they experienced telemetry signal noise intermittently on multiple channels on their loaner telemetry system (wep) device.
Additional Manufacturer Narrative
Manufacturer narrative: the customer reported that they experienced telemetry signal noise intermittently on multiple channels on their loaner telemetry system (wep) device.After some troubleshooting, it was determined that this was not the result of interference and that the wep loaner device will need to be exchanged due to the failure of that device.The defective loaner was returned and evaluated.The issue could not be duplicated.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: WEP-4208A
• Common Device Name: TELEMETRY MONITORING SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• MDR Report Key: 6077979
• Report Number: 8030229-2016-00536
• Device Sequence Number: 18985296
• Product Code: MHX
• UDI-Device Identifier: 04931921114957
• UDI-Public: 04931921114957
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2016
• Report Date (Section F): 11/03/2016

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
• Operator of Device: Health Professional
• Device Model Number: WEP-4208A
• Device Catalogue Number: WEP-4208A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/04/2016
• Device Age: 119 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2016
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/03/2016