MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems Display Difficult to Read (1181); Output Problem (3005)

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

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

There was no clarification on whether the red block obscured the view of on-screen patient vitals and attempts to obtain this clarification were not answered by the customer.This cns has been sunshined.The customer attempted to replace the monitor on the unit, which did not resolve the issue due to incompatibility issues with the sunshined cns.They were provided with an exchanged unit, but the failed unit has not yet been received by nihon kohden for evaluation.No patient harm was reported.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: concomitant medical products.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) had a solid red block across the top of the display screen.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at (b)(6) medical ctr reported that the display (a/24-canvys) on the central nurse's station (cns) had a solid red block across the top.The customer changed the display and the issue appeared to be following the screen.Service requested: exchange.Service performed: exchange of (a/24-canvys) display; nka repair center evaluation of returned unit: evaluated a/24-canvys s/n (b)(6).The unit was cleaned and decontaminated.Investigation summary: the issue was reported for the cns canvys display.There was no reported issue with the device (pu-681ra sn:(b)(6)).Nka repair center evaluation was unable to duplicate the reported issue.The screen was found to be working normally, with no sign of red block or any glitch.As evaluation of the unit was unable to reproduce the reported issue, the root cause could not be determined.No risk assessment is performed as the evaluation did not identify a non-conformance.After the exchange of the canvys monitor, the customer reported continuing display issues on the cns under ticket 63644.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) had a solid red block across the top of the display screen.

• Brand Name: CNS-6801A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 8899781
• MDR Text Key: 196270080
• Report Number: 8030229-2019-00378
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/07/2019

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: CNS-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2019
• Distributor Facility Aware Date: 03/26/2020
• Device Age: 30 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1