MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION

Model Number EDNS-9001

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

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

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 when additional information becomes available.

Event Description

Customers reports that when a patient is monitored for spo2 only (no ecg) on a transmitter for the prefense system (with ecg measurements turned off), spo2 value does not display in the patient tile on the home screen as it should.

Manufacturer Narrative

Manufacturer narrative: customer report that when a patient is monitored for spo2 only (no ecg) on a transmitter for the prefense system (with ecg measurements turned off), spo2 value does not display in the patient tile on the home screen as it should.The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: CENTRAL MONITORING SYSTEM
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan CA 161-8 560; JA 161-8560
• Manufacturer (Section G): NKUS LAB; 5 jenner, suite 180; attn: shama mooman; gunma CA ; JA
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgm; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687708
• MDR Report Key: 5435842
• MDR Text Key: 38773625
• Report Number: 2032233-2016-00061
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

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: EDNS-9001
• Device Catalogue Number: EDNS-9001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• 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