MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION RNS-9703-019; REMOTE NETWORK STATION

Model Number RNS-9703-019

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

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

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 when additional information becomes available.

Event Description

The customer reported that the monitor on the rns (remote network system or remote monitoring system) has a dimmed backlight and you can barely see the display.

Manufacturer Narrative

Manufacturer narrative: the customer reported that the monitor has a dimmed backlight and that they can barely see the display.The unit was evaluated and the reported problem was duplicated.The dimmed backlight problem during boot up was confirmed.Tried adjusting the intensity, but in vain.After being used for a while, the display becomes blank.Due to the age of this complaint additional information necessary to conduct an investigation is not readily available.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: RNS-9703-019
• Type of Device: REMOTE NETWORK STATION
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan CA 161-8 560; JA 161-8560
• Manufacturer (Section G): NKUS LAB; 5 jenner, suite 180; attn: shama mooman; gunma CA ; JA
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgm; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687708
• MDR Report Key: 5339721
• MDR Text Key: 35262094
• Report Number: 2032233-2015-00479
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023475
• 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: 12/03/2015

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: RNS-9703-019
• Device Catalogue Number: RNS-9703-019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 01/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2013
• 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