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

Model Number CNS-6201A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) automatically discharged a transmitter being monitored on it.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.The following fields are not applicable (n/a) to the mdr report.

Event Description

The nurse reported that the central nurse's station (cns) automatically discharged a transmitter being monitored on it.No patient harm was reported.

Manufacturer Narrative

Complaint details: the customer reported on 04/17/2019 that their cns automatically discharged the transmitter.Service requested: troubleshooting.Service provided: logs were collected from the customer to determined the cause.Investigation result: the cns (pu-621ra; sn: (b)(6) was placed into service on 05/24/14, which is over 4 years prior to the reported issue.A review of device history found the following complaints previously reported: 300008662- unable to use touch screen; root cause: user error 300086305- software update request; root cause: assistance needed, not a device malfunction similar tickets using "cns automatically discharged transmitter" and "cns discharged transmitter" found no similar complaints.Similar tickets using "cns discharged tele" found the following: 314- customer wanted to know if they can look at patient data once they discharged them; root cause: user education 14645-cns discharging patients on its own; root cause: user error there does not appear to be an adverse trend with this unit.The root cause of the issue was unable to be determined as further information was not provided by the customer.Based on the device service history and similar complaints, user error/education was prevalent.Corrected information: f9.Approximate age of device: incorrectly calculated.G4.Date received by manufacturer: should be 04/17/2019 not 05/16/2019 as listed on mdr initial report.

Event Description

The nurse reported that the central nurse's station (cns) automatically discharged a transmitter being monitored on it.No patient harm was reported.

• 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: 8618308
• MDR Text Key: 145400988
• Report Number: 8030229-2019-00156
• 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: 10/02/2019

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-6201A
• Device Catalogue Number: PU-621RA
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2019
• Distributor Facility Aware Date: 10/02/2019
• Device Age: 62 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1