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

Model Number CNS-6801A

Device Problems Application Program Problem (2880); Output Problem (3005)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the beds dropped off the central nurse's station (cns).They do not know if the beds were in use or not.They do not know if patients were being monitored in these beds at the time.However, each of these beds were filing both locally and remotely (at two different locations), meaning the patient (if applicable) was still being monitored in one place or the other.Patient use is unknown.(b)(6) 2024 - missing beds vmc-cv221 device model and serial number unknown vmc-cv222 device model and serial number unknown vmc-cv223 device model and serial number unknown.(b)(6) 2024 - missing beds vmc-cv222 device model and serial number unknown vmc-cv224 device model and serial number unknown.Additional device information: d10: concomitant medical device: the following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.

Event Description

The biomedical engineer (bme) reported that the beds dropped off the central nurse's station (cns).They do not know if the beds were in use or not.They do not know if patients were being monitored in these beds at the time.However, each of these beds were filing both locally and remotely (at two different locations), meaning the patient (if applicable) was still being monitored in one place or the other.Patient use is unknown.(b)(6) 2024 - missing beds vmc-cv221 device model and serial number unknown vmc-cv222 device model and serial number unknown vmc-cv223 device model and serial number unknown.(b)(6) 2024 - missing beds vmc-cv222 device model and serial number unknown vmc-cv224 device model and serial number unknown.

• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 19056343
• MDR Text Key: 340458443
• Report Number: 8030229-2024-04208
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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
• Report Date: 04/05/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2017
• 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