MAUDE Adverse Event Report: NIHON KOHDEN ORANGEMED, LLC NIHON KOHDEN NKV-330 VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number NKV-330

Device Problem Unintended Application Program Shut Down (4032)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that during patient use, the nkv-330 ventilator was alarming circuit disconnect and o2 supply low and went into standby mode.The patient was able to remove the noninvasive facemask and call for assistance.The patient''s oxygen saturation dropped to 83%.The patient recovered quickly and was placed on another ventilator.There was no harm to the patient.A review of the debug logs confirmed that the ventilator had multiple circuit disconnects and o2 supply low alarm activations.When the circuit disconnect alarm is active, the ventilator stops ventilation until it detects a circuit connection or is manually restarted.The o2 supply low alarm occurs when the oxygen supply pressure to the high-pressure oxygen port is less than (b)(4).After this incident was reported to nkom, the hospital checked their oxygen supply lines to patient rooms in this area of the hospital and discovered that the pressure was lower than in other areas.

Manufacturer Narrative

Nihon kohden orangemed inc.Will submit a supplemental report if additional information becomes available.

• Brand Name: NIHON KOHDEN NKV-330 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: 18754932
• MDR Text Key: 336761975
• Report Number: 3014631252-2024-00010
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213521
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NKV-330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 151 KG