MAUDE Adverse Event Report: NIHON KOHDEN ORANGEMED, INC. NIHON KOHDEN; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number NKV-550

Device Problems Poor Quality Image (1408); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 05/07/2023

Event Type  malfunction  

Event Description

Ventilator was in use but was not being touched at the time of this incident, when it spontaneously turned off and started to sound a high-pitched alarm.At this time, the ventilator screen was black, the system was completely turned off, and there was a continuous red color alarm on the top of the screen.

• Brand Name: NIHON KOHDEN
• 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: 17001886
• MDR Text Key: 315923655
• Report Number: 17001886
• 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: 05/17/2023,05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NKV-550
• Device Catalogue Number: NKV-550
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1460 DA
• Patient Sex: Female
• Patient Weight: 17 KG
• Patient Ethnicity: Hispanic