MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems No Display/Image (1183); Device Stops Intermittently (1599)

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

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the monitor on the central nurse's station (cns) went out and was no longer displaying an image on the screen.He stated that the nurse told him that half of the monitor screen had horizontal lines going through it, then they went away but not long after that the whole screen went black.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 if additional information becomes available.

Event Description

The biomedical engineer reported that the monitor on the central nurse's station (cns) went out and was no longer displaying an image on the screen.He stated that the nurse told him that half of the monitor screen had horizontal lines going through it, then they went away but not long after that the whole screen went black.

Manufacturer Narrative

Details of complaint: on (b)(6) 2018 customer stated the cns device was experiencing display issue - blank screen.Customer biomed relayed the message the nurses stating that the screen had horizontal lines going through it, then went away, and shorter after the screen went blank.Device was not sent to nka for evaluation.Nk tech support made attempts to follow up on with customer but received no responses.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: device was put into service on (b)(6) 2013.Service history shows device does not have a history of display issues.Due to limited information available, the root cause of the screen failure could not be determined.

Event Description

The biomedical engineer reported that the monitor on the central nurse's station (cns) went out and was no longer displaying an image on the screen.He stated that the nurse told him that half of the monitor screen had horizontal lines going through it, then they went away but not long after that the whole screen went black.

• Brand Name: CNS-6201A
• 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: 7470656
• MDR Text Key: 106855314
• Report Number: 8030229-2018-00137
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 4931921114131
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6201A
• Device Catalogue Number: PU-621RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2019
• Distributor Facility Aware Date: 10/07/2019
• Device Age: 59 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2019
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1