• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS AZURION 7 B20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

  • 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
 

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS AZURION 7 B20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 92406752
Device Problems Display or Visual Feedback Problem (1184); Vibration (1674); Intermittent Energy Output (4025)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2023
Event Type  malfunction  
Event Description
During roadmap use, when the physician performs a dsa or single-shot acquisition, and then returns to roadmap use, the roadmap starts shaking or turning dark and becoming unusable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PHILIPS AZURION 7 B20
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
MDR Report Key16953645
MDR Text Key315549771
Report NumberMW5117643
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/15/2023
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 Number92406752
Device Catalogue Number722226
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/17/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age77 YR
Patient SexFemale
Patient Weight81 KG
Patient EthnicityNon Hispanic
-
-