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

Model Number CNS-6801A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

The customer reported that a bedside monitor (bsm-6000) dropped off the central nurse's station (cns).The customer doesn't know when the bed was removed from the cns.The customer will provide the cns logs.The logs were examined and it was discovered that there seems to be an issue with the software.Software 02-24 will be released to correct this issue.There was no patient injury reported.Investigation summary: the logs were examined and it was discovered that there seems to be an issue with the software.Software 02-24 will be released to correct this issue.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the cusotmer replied by stating unknown.B6 attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the cusotmer replied by stating unknown.B7 attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the cusotmer replied by stating unknown.D10 concomitant medical device: the following device was used in conjunction with the cns: bsm: model #: mu-671ra serial #: (b)(6).Device manufacturer date: 06/03/2010 unique identifier (udi) #: (b)(4).Returned to nihon kohden: no.

Event Description

The customer reported that a bedside monitor (bsm-6000) dropped off the central nurse's station (cns).There was no patient injury reported.

• 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: 19135838
• MDR Text Key: 340516796
• Report Number: 8030229-2024-04237
• 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: 04/18/2024

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: 03/21/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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: MU-671RA