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

Model Number NKV-550-U

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/12/2024

Event Type  malfunction  

Event Description

It was reported that the nkv-550 ventilator was in the o2 therapy mode on a patient.The registered therapist (rt) heard the ventilator make a loud steady alarm noise.When the rt entered the room the ventilator had shut down and the patient had desaturated to 80%.The registered nurse manually ventilated the patient and the patient quickly recovered.The rt restarted the ventilator and it started back up in the same mode- o2 therapy at the same previous set settings.The patient was placed back on the ventilator in the o2 therapy mode.A few hours later the patient was placed on another ventilator.Based on the debug log analysis, it was confirmed that ventilation resumed successfully after the momentary system restart.

• Brand Name: NIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NIHON KOHDEN ORANGEMED, LLC; 1800 e. wilshire ave.; santa ana CA 92705
• Manufacturer (Section G): NIHON KOHEN ORANGEMED, LLC; 1800 e. wilshire ave.; santa ana CA 92705
• Manufacturer Contact: sheryl higgins ; 1800 e. wilshire ave.; santa ana, CA 92705 ; 949502644
• MDR Report Key: 18842970
• MDR Text Key: 337688885
• Report Number: 3014631252-2024-00011
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00843685100012
• UDI-Public: 00843685100012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NKV-550-U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 76 KG