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 Problems Failure to Cycle (1142); No Tactile Prompts/Feedback (4024)

Patient Problems Low Oxygen Saturation (2477); Increased Respiratory Rate (2486)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Device is still under failure investigation, once more information is obtained a follow up summary will be reported.

Event Description

The rt (respiratory therapist) was paged to the patients room for a non-functioning ventilator.When the rt arrived to the room, the rn (registered nurse) had placed the patient on a trach collar.The patient had a spo2 of 100% and was tachypneic.The rt was told by the rn that the patient had experienced desaturations into the 70''s with an increased work of breathing and the ventilator was not delivering any breaths.The rt placed the patient on another ventilator in the acvc mode which resulted in instant improvement.Patient has been since weaned to psv.Additional information gathered later from the rt states that ventilator did not shut down, it froze with the lights still on.

Manufacturer Narrative

Failure investigation complete, refer to attached report for details.

• 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: 11667849
• MDR Text Key: 280537595
• Report Number: 3014631252-2021-00029
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other