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: AEROGEN LTD AEROGEN PRO-X CONTROLLER; NEBULIZER (DIRECT PATIENT INTERFACE)
  • 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
 

AEROGEN LTD AEROGEN PRO-X CONTROLLER; NEBULIZER (DIRECT PATIENT INTERFACE) Back to Search Results
Device Problems Failure to Deliver (2338); Output Problem (3005); Protective Measures Problem (3015); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Arrhythmia (1721); Low Oxygen Saturation (2477)
Event Date 03/13/2021
Event Type  Injury  
Event Description
Patient on continuous flolan via aerogen nebulizer for pphn.The cord connecting the nebulized medication cup to the machine stopped working, resulting in the flolan not being delivered to the patient for approximately 1.5 hours.The patient began to desaturate, had increased hr, required more medications and increased ventilator support.The cord was replaced, the medication began nebulizing again, and the patient began to recover without any more interventions, leading me to believe that was what caused the problem in the first place.When the flolan stops nebulizing, there is no way for it to alarm to notify staff.Currently rt check the flolan q2 to make sure it is nebulizing, but it is very difficult to see and can be easily missed.If there was another way for the machine to actually alarm at us when it stops nebulizing, i think that would be more accountable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AEROGEN PRO-X CONTROLLER
Type of Device
NEBULIZER (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
AEROGEN LTD
EI 
MDR Report Key11553028
MDR Text Key242061834
Report NumberMW5100176
Device Sequence Number1
Product Code CAF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age1 MO
Patient Weight5
-
-