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

Model Number CNS-6201A

Device Problems No Audible Alarm (1019); Use of Incorrect Control/Treatment Settings (1126); Human-Device Interface Problem (2949)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) gave no audio vent alarm.Nihon kohden technical service advised that the technical alarms cannot be turned off and on.This was an advisory alarm and she would have heard a pinging noise, however they may have missed it if the volume was turned down or the alarm was silenced.This was an alarm settings issue, which is considered to be a use error situation.To resolve the issue, she was provided with training materials on how to configure the alarm settings.

Event Description

The biomedical engineer reported that the central nurse's station (cns) gave no audio vent alarm.

Manufacturer Narrative

Details of complaint on (b)(6) 2018 customer stated that the advisory ventilator alarm at the cns did not make any audible sound.Nk cas explained that is no option for technical alarms such as ventilator alarm to be on or off.Thus, the advisory alarm would make a "ping" noise.If volume on the device was low or silenced, the noise may not have been heard.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: pu-621ra serial # (b)(6) was put into service on(b)(6) 2015.Service history shows this is an isolated incident.As the reported issue could not be confirmed, device's volume setting is unknown at the time of the incident, and customer has not reported similar incidents, the root cause of the inaudible alarm could not be determined.

Event Description

The biomedical engineer reported that the central nurse's station (cns) gave no audio vent alarm.

• 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: 7623416
• MDR Text Key: 111841597
• Report Number: 8030229-2018-00215
• 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: 10/18/2019

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: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2019
• Distributor Facility Aware Date: 10/09/2019
• Device Age: 41 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2019
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1