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); Poor Quality Image (1408)

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

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.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 rns (remote network system or remote monitoring system) is dim and cannot see "all beds" screen.

Manufacturer Narrative

The customer reported that the rns (remote network system or remote monitoring system) is dim and cannot see "all beds" screen.The unit was evaluated and the reported problem was duplicated.The customer identified the cause of the malfunction.A replacement module or component was sent to the customer.Based on the information provided at the time of the event assessment, there is no indication that was a patient injury or a reportable event as a result of this issue.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: 5158608
• MDR Text Key: 28930145
• Report Number: 2032233-2015-00308
• 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: 09/17/2015

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: 10/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2015
• Initial Date FDA Received: 10/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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