MAUDE Adverse Event Report: NIHON KOHDEN ORANGEMED, INC. NIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number NKV-550-U

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.A supplemental report will be issued if additional information is obtained.

Event Description

It was reported that there was an oxygen leakage from below the device during patient use.After patient was removed the ventilator, the user checked the service screen and the o2 inlet pressure reading was 20.0 psi.No other details have been provided even after multiple attempts by manufacturer.This mdr will be updated once more details are obtained.

Manufacturer Narrative

Evaluation complete.See attached evaluation summary report.

• Brand Name: NIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NIHON KOHDEN ORANGEMED, INC.; 1800 e. wilshire ave.; santa ana CA 92705
• MDR Report Key: 11593173
• MDR Text Key: 243156984
• Report Number: 3014631252-2021-00024
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00843685100012
• UDI-Public: 00843685100012
• Combination Product (y/n): Y
• PMA/PMN Number: K181695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NKV-550-U
• Device Catalogue Number: NKV-550-U
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other