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 Operating System Becomes Nonfunctional (2996)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/06/2022

Event Type  malfunction  

Event Description

The patient started to desaturate.The respiratory therapist tried to increase fio2 through the touchscreen.The screen was frozen and unresponsive, but the screen was not locked nor wet.However, the ventilator continued to ventilated the patient.The patient was disconnected from the ventilator and hand-bagged so the ventilator could be changed.

• 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 avenue; santa ana CA 92705
• MDR Report Key: 16662799
• MDR Text Key: 312513347
• Report Number: 16662799
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2023,02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NKV-550-U
• Device Catalogue Number: NKV-550-U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7 DA
• Patient Sex: Male
• Patient Weight: 4 KG
• Patient Race: Asian