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

Model Number	WEP-4208A
Medical Device Problem Codes	Radiofrequency Interference (RFI) (2314); Device Displays Incorrect Message (2591); Device Operational Issue (2914); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the wep telemetry system signal showed a zig zag waveform on multiple channels.The customer sent the unit in for evaluation and repair and the evaluation has not yet been conducted.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 the wep telemetry system signal showed a zig zag waveform on multiple channels.
Additional Manufacturer Narrative
The customer reported that the wep telemetry system signal showed a zig zag waveform on multiple channels.The customer sent the wep telemetry system unit in for evaluation and repair.The unit was cleaned and evaluated.The reported problem could not be duplicated through testing, troubleshooting and extended operation of the unit.Review of the device history indicates no previous cnd status.The unit was tested per the operator's manual and the results were recorded on the maintenance check sheet.The unit operates to manufacturer's specifications.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.

• Brand Name: WEP-4208A
• Common Device Name: TELEMETRY MONITORING SYSTEM
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• MDR Report Key: 6301066
• Report Number: 8030229-2017-00023
• Device Sequence Number: 1102655
• Product Code: MHX
• UDI-Device Identifier: 04931921114957
• UDI-Public: 4931921114957
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/05/2017
• Report Date (Section F): 02/03/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/05/2017
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 03/08/2017
• 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: 02/03/2017