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

Model Number CNS-6281

Device Problem Human-Device Interface Problem (2949)

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

Event Date 05/04/2019

Event Type  malfunction  

Manufacturer Narrative

On-site technicians corrected the settings, which resolved the issue.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.(b)(4).

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) sent vitals from room 2020 to the wrong patient.

Manufacturer Narrative

Complaint summary - on 5/4/19 at 3:15 in room 2020 , (b)(6) (clinical engineering site specialist at (b)(6) medical center) reported the central monitoring room was unable to see the waveform for an individual patient, while other cnss were able to view the waveform.The occurrence is ongoing but inconsistent.Service requested - troubleshooting.Service performed - an irc was sent to nkc on 6/4/2019 with photos and logs.Investigation results - it has been confirmed that the cns real-time waveform may not be display in wlan transport for this version of cns software (02-08).A countermeasure has been taken in cns version 02-13.Corrected information: d4.Model number.Additional information: b4.Date of this report; f6.Date user facility/importer became aware of the event; f7.Type of report; f11.Date report sent to fda; f13.Date report sent to manufacturer; g4.Date received by manufacturer; g7.Type of report; h2.If follow-up, what type? ; additional information; correction; h6.Event problem and evaluation codes; h10.Additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) sent vitals from room 2020 to the wrong patient.

• Brand Name: CNS
• 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: 8660428
• MDR Text Key: 147320236
• Report Number: 8030229-2019-00195
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

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-6281
• Device Catalogue Number: PU-681RA
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2020
• Distributor Facility Aware Date: 12/26/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2020
• Initial Date Manufacturer Received: 05/04/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1