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

Model Number	WEP-4208A
Medical Device Problem Codes	Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Inoperable (1663)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the telemetry system (wep) device was booting to a "system diagnostic check" screen that displayed a "main board failure" error message.The customer sent the unit in to nihon kohden for repair and it is currently awaiting evaluation.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 telementry system (wep) device was booting to a "system diagnostic check" screen that displayed a "main board failure" error message.
Additional Manufacturer Narrative
Manufacturer narrative: the customer reported that the telemetry system (wep) device was booting to a "system diagnostic check" screen that displayed a "main board failure" error message.The customer sent the unit in to nihon kohden for evaluation.The unit was cleaned and evaluated.The reported problem could not be duplicated through testing, trouble shooting, and extended operation of the device.The unit booted up to the patient monitoring software as it should and all receivers were working properly.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: 6284949
• Report Number: 8030229-2017-00012
• Device Sequence Number: 19045795
• Product Code: MHX
• UDI-Device Identifier: 04931921114957
• UDI-Public: 04931921114957
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2016
• Report Date (Section F): 01/27/2017

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: 01/12/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/28/2016
• Device Age: 74 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2017
• 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: 01/27/2017