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: VYAIRE MEDICAL, INC. BIRD O2 BLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION
  • 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
 

VYAIRE MEDICAL, INC. BIRD O2 BLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION Back to Search Results
Model Number 3800A
Device Problem Failure to Deliver (2338)
Patient Problem Low Oxygen Saturation (2477)
Event Date 02/11/2021
Event Type  Injury  
Event Description
This patient was moved into a new room on a bubble cpap at 35%.Shortly after being in his new room he was in severe respiratory distress with desaturations into the 60s.The blender had been turned up to 100% without any improvement.The nurse practitioner was called to bedside and a stat chest xray was ordered.Md arrived at bedside.The patient had to receive emergency intubation, morphine, and atropine because he was decompensating so quickly.Once the patient was placed on the ventilator, he improved significantly and we were able to wean his oxygen.We decided to check the blender with an fio2 analyzer and found that this patient's blender does not deliver any oxygen over 21%.It is unclear how long this equipment has been broken or how many patients have been affected negatively from it and received unnecessary treatments because of it.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BIRD O2 BLENDER
Type of Device
MIXER, BREATHING GASES, ANESTHESIA INHALATION
Manufacturer (Section D)
VYAIRE MEDICAL, INC.
MDR Report Key11365134
MDR Text Key233466945
Report NumberMW5099553
Device Sequence Number1
Product Code BZR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/19/2021
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 Number3800A
Device Catalogue Number3800A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/22/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age4 DA
-
-