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: PHILIPS HEALTHCARE ALLURA XPER FD20; 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 HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 722028
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still ongoing for this event.When the investigation is completed a follow-up will be sent to the fda.
 
Event Description
Initial report: it has been reported to philips that the l-arm rotational cover came off.The system was not in clinical use and no harm was reported.Philips has started an investigation for this complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.Philips confirmed with the customer that the l-arm rotation cover came off as a result of a collision with a lamp in the exam room.The system was not in clinical use at the time that the incident occurred and there was no harm to any user or bystander.Philips has inspected the system on site.The cover was re-attached and the system was returned to use in good working order.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALLURA XPER FD20
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
p.o. box 10.000
best 5680 DA
NL  5680 DA
MDR Report Key10282689
MDR Text Key199659748
Report Number3003768277-2020-00038
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
PMA/PMN Number
K141979
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722028
Device Catalogue Number722028
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-