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 Application Program Problem: Parameter Calculation Error (1449)

Patient Problem Respiratory Failure (2484)

Event Type  malfunction  

Manufacturer Narrative

A software bug was identified regarding the numeric monitors during cpap mode.In all cases the patient is receiving the correct respiratory support through cpap as set by the clinician and the displayed waveforms are graphically correct.Because the patient respiratory support is not affected and the graphic monitors function correctly, this software bug did not cause any adverse impact to the patient.

Event Description

It was reported that during spontaneous cpap with 9 cmh2o the displayed monitor values were reading very high airway pressures, it wasn't recording tidal volumes, peep, respiratory rate.The patient was stable and oxygenated at all times.

• 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
• Manufacturer (Section G): NIHON KOHEN ORANGEMED, INC.; 1800 e. wilshire ave.; santa ana CA 92705
• Manufacturer Contact: sheryl higgins ; 1800 e. wilshire ave.; santa ana, CA 92705 ; 949502644
• MDR Report Key: 10124812
• MDR Text Key: 209400299
• Report Number: 3014631252-2020-00001
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): Y
• Reporter Country Code: EI
• PMA/PMN Number: K181695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• 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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 81