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

Model Number CNS-6801A

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) was in comm loss with the gz transmitters.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.Concomitant medical device: the following devices were being used in conjunction with the cns: gz transmitters: model: ni.S/n: ni.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was in comm loss with the gz transmitters.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was in comm loss with the gz transmitters.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was in comm loss multiple gz transmitters for about 10 seconds.No patient harm or injury was reported.Investigation summary: as the issue resolved on its own, and no additional information could be obtained from the customer, a root cause could not be determined.A review of the serial number history shows no recurrence of the reported issue.Due to the complex nature of hospital network systems, these issues may recur despite correctly functioning equipment.

• Brand Name: CNS-6801A
• 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: 10376939
• MDR Text Key: 204184687
• Report Number: 8030229-2020-00431
• Device Sequence Number: 1
• Product Code: MHX
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/06/2020,02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2020
• Distributor Facility Aware Date: 07/10/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2020
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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: GZ TRANSMITTERS; GZ TRANSMITTERS