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 No Display/Image (1183); Defective Component (2292)

Patient Problems Respiratory Failure (2484); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2020

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned for evaluation yet.A supplemental report will be issued if additional information is obtained.

Event Description

It was reported by the respiratory therapist that he heard the ventilator alarming with a constant alarm sound.The nurse was asked to check on the patient because the therapist was in another room.The nurse reported the screen was blank, and when therapist went into the room, the screen was in the process of rebooting.There was no harm to the patient due to episode.

Manufacturer Narrative

Evaluation complete.See attached evaluation summary report.

• 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: 11244965
• MDR Text Key: 241554036
• Report Number: 3014631252-2021-00003
• 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: 08/12/2021

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 Operator: Health Professional
• Device Model Number: NKV-550-U
• Device Catalogue Number: NKV-550-U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 75