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 No Display/Image (1183)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during patient use, the graphic user interface display screen froze.The breath delivery unit continued to ventilate patient as designed.No patient harm was noted.

Manufacturer Narrative

Update: it was reported that the graphic user interface (gui) display screen froze while on a patient, no buttons on the display screen were functioning.The bdu (breath delivery unit) continued to function as designed.Staff removed the patient from the ventilator, turned the unit off and on, the issue was resolved.They used the ventilator for another 5 hours on the patient.No issues were found.There was no serious injury or death to the patient while on the ventilator.The actual device has been returned and evaluated.Analysis of the log files verified that the graphic user interface (gui) screen freezing was limited to the waveform and numeric areas of the screen.The event occurred because the monitor's thread stopped working and the user interface stopped receiving data.However, the breath delivery unit continued to ventilate the patient as designed.The primary control area buttons, app area buttons on the control panel, and the encoder knob functioned normally.Device evaluation included 900 consecutive hours of continuous ventilation with no repeat of the failure observed.The reported graphic user interface display screen freeze could not be duplicated.

• 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: 10521964
• MDR Text Key: 218975119
• Report Number: 3014631252-2020-00003
• 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
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• 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: 09/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 MO
• Patient Weight: 4