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

Model Number CNS-6801A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) discharged 5 transmitters without any user intervention.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.Concomitant medical devices were requested from the customer but the information was not provided.

Event Description

The customer reported that the central nurse's station (cns) discharged 5 transmitters without any user intervention.No patient harm was reported.

Manufacturer Narrative

Details of the complaint on (b)(6) 2019, monitor tech amy martinez at northwest medical center reported the cns-6801a (pu-681ra sn(b)(6) discharged 5 patients without anyone doing so.She believed the issue started the previous night and into the morning, affecting a total of 5 patients.The tile and transmitter were still showing on the cns but no patient was admitted to them.She verified the patients were on zm telemetry.Service requested troubleshooting/assistance service performed additional information and log files were collected.Hayley provided further information for the 5 tele patients that discharged off the cns by themselves.Further information was requested however multiple follow up attempts were unable to obtain customer response.Investigation result the cns warranty began (b)(6) 2019, which is less than 3 months prior to the reported issue.Review of device sap history found no other reported issues with patient discharge.Irc-nka300175755 was initiated (b)(6) 2019 to investigate the patient discharge.Evaluation of the customer's ip configuration shows an rns is installed at customer facility.As patient discharge can occur from the rns, log of the rns was needed to further investigate.Multiple attempts were made to reach out to the customer via phone and email in order to obtain further information needed for investigation, however customer was unresponsive.From the information available, the root cause could not be confirmed.Review of tickets opened at customer facility found no other reported issues with "discharge".No adverse trend for this issue is suspected at customer facility.

Event Description

The customer reported that the central nurse's station (cns) discharged 5 transmitters without any user intervention.No patient harm was reported.

• 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: 8843846
• MDR Text Key: 153255191
• Report Number: 8030229-2019-00312
• 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: 11/06/2019

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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2019
• Distributor Facility Aware Date: 10/28/2019
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: 07/07/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GZ TRANSMITTER MODELS AND SN NOT PROVIDED; GZ TRANSMITTER MODELS AND SN NOT PROVIDED