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

Model Number CNS-6201A

Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station's (cns) was showing signal loss with the tele devices after a generator test.No patient harm was reported.During troubleshooting, it was found that the host table was empty and that the allied telesys switch, connecting the devices to this cns, was powered off.The power plug had been pulled from the switch and plugging it back in 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 when additional information becomes available.Additional device information: concomitant medical products: the following devices were being used in conjunction with the cns: transmitters: no model or serial numbers were provided.(b)(4).

Event Description

The customer reported that the central nurse's station's (cns) was showing signal loss with the tele devices after a generator test.No patient harm was reported.

Manufacturer Narrative

The customer reported that the central nurse's station's (cns) was showing comm loss with the telemetry devices after a generator test.No patient harm was reported.During troubleshooting, it was found that the host table was empty and that the allied telesys switch, connecting the devices to this cns, was powered off.The power plug had been pulled from the switch and plugging it back in resolved the issue.No patient harm was reported service requested / performed: troubleshooting.Investigation summary: the customer indicated that the comm loss issue occurred after a generator test.The customer identified that the cause of the issue was that the switch connecting the monitored devices and the cns was unplugged.After the switch was plugged in and power was restored, the issue was resolved.Based on the available information, the most probable cause of the issue is human error.A staff may have accidentally unplugged the switch during the activities tied to the generator test.The overall risk rating of the event is high.Hha 2021-006 was performed to assess issues regarding comm loss.Per hha, no capa is required.Furthermore, available information does not suggest that there was a malfunction of the device additional information: b4 date of this report d8 was this device serviced by a third party? g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The customer reported that the central nurse's stations (cns) was showing comm loss with the telemetry devices after a generator test.No patient harm was reported.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10518472
• MDR Text Key: 207155964
• Report Number: 8030229-2020-00524
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRANSMITTERS; TRANSMITTERS