Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN ORANGEMED, LLC. NKV-330; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NIHON KOHDEN ORANGEMED, LLC. NKV-330; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number NKV-330
Patient Problem Low Oxygen Saturation (2477)
Event Date 12/29/2023
Event Type  malfunction  
Event Description
Patient on nkv-6 ventilator needed to be intubated in medical-surgical and neuroscience intensive care unit (msnicu).When about to transport patient, staff opened both oxygen tanks all the way, then attempted to connect oxygen hose to oxygen y-connector.They were unable to connect.4 people attempted until it finally clicked in place.Then, alarm on nkv said low o2 supply.Patient oxygen saturation (spo2) dropped to 40%.Manufacturer response for nkv, nkv (per site reporter).Staff skill knowledge level and inexperience with connection.O2 alarm situation, which is corrected with a software upgrade.This upgraded software was carried out on all of the nkv-330 units onsite inbound.Software addresses analyzed fraction of inspired oxygen (fio2) points.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NKV-330
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
Manufacturer (Section D)
NIHON KOHDEN ORANGEMED, LLC.
1800 e. wilshire avenue
santa ana CA 92705
MDR Report Key18767728
MDR Text Key336114935
Report Number18767728
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/09/2024
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 NumberNKV-330
Device Catalogue NumberNKV-330
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/09/2024
Date Report to Manufacturer02/21/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/23/2024
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age64 YR
-
-