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

Model Number CNS-6281

Device Problems Incorrect Measurement (1383); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2019

Event Type  malfunction  

Manufacturer Narrative

On-site technicians corrected the settings, which 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 if additional information becomes available.(b)(4).

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) sent vitals from room 2010 to the wrong patient.

Manufacturer Narrative

Details of the complaint on (b)(6) 2019, bme daniel aro at scl health system reported the (b)(4) had incorrect vitals.Service requested troubleshooting/assistance service performed issue was resolved by adjusting settings investigation result the root cause is determined to be user error.Issue was resolved by changing settings as appropriate.This issue is not suspected to be caused by deficient device or design.Review of similar tickets using keywords "pu-681ra vitals" found no other issues which may be related.No adverse trend suspected.Corrected information: d4.Model number additional information: b4.Date of this report f6.Date user facility/importer became aware of the event f7.Type of report f11.Date report sent to fda f13.Date report sent to manufacturer g4.Date received by manufacturer g7.Type of report h2.If follow-up, what type? additional information correction h6.Event problem and evaluation codes h10.Additional manufacturer narrative the following fields are not applicable (n/a) to this report: a2 - a6 b2 b6 b7 d4 lot # & expiration date d6 - d7 d9 d11& c2 f10 g6 g8 h7 h9.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) sent vitals from room 2010 to the wrong patient.

• Brand Name: CNS
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 8660433
• MDR Text Key: 147319265
• Report Number: 8030229-2019-00194
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2019
• Distributor Facility Aware Date: 09/09/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2019
• Initial Date Manufacturer Received: 05/04/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1