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

Model Number CNS-6281

Device Problems Application Program Problem (2880); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the bed names and patients were being switched without user interactions on the central nurse's station (cns).The tile was supposed to be occupied by a bedside on the 5th floor and instead had a bed on the 6th in its tile.No patient harm reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Concomitant medical devices: csm-1901 (cu-192ra), serial number not available.

Event Description

The customer reported that the bed names and patients were being switched without user interactions on the central nurse's station (cns).The tile was supposed to be occupied by a bedside on the 5th floor and instead had a bed on the 6th in its tile.No patient harm reported.

Manufacturer Narrative

Details of complaint: on 05/31/2019, the customer reported bed names and patients were being switched without user interaction.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: due to the age of this complaint, new information cannot be made available.Root cause cannot be determined.The rpn of this issue is medium.A capa will not be initiated due to the low occurrence of this issue.The following fields are not applicable (na) to the mdr report: b2.B6.B7.D4 lot # & expiration date.D6a & d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H7.H9.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: g9 monitor: model #: csm-1901.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Additional information: b4 date of this report.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 bed names and patients were being switched without user interations on the central nurse's station (cns).The tile was supposed to be occupied by a bedside on the 5th floor and instead had a bed on the 6th in its tile.No patient harm reported.

• Brand Name: CNS
• 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
• MDR Report Key: 8725282
• MDR Text Key: 149504657
• Report Number: 8030229-2019-00233
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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: 06/21/2019,07/09/2021

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-6281
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2019
• Distributor Facility Aware Date: 05/31/2019
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2019
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CSM-1901; G9 MONITOR