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

Model Number WEP-4208A

Device Problems Radiofrequency Interference (RFI) (2314); Device Displays Incorrect Message (2591); Device Operational Issue (2914); Wireless Communication Problem (3283)

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

Event Date 01/05/2017

Event Type  malfunction  

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 Description

The customer reported that the wep telemetry system signal showed a zig zag waveform on multiple channels.

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
• Type of Device: 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
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer Contact: susan shadley ; 1-31-4 nishiochiai, shinjuku-k; attn: susan shadley; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687133
• MDR Report Key: 6301066
• MDR Text Key: 66505097
• Report Number: 8030229-2017-00023
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114957
• UDI-Public: 4931921114957
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/03/2017,01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2017
• Distributor Facility Aware Date: 01/05/2017
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2017
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1