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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number ALLURA XPER FD20
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2022
Event Type  malfunction  
Manufacturer Narrative
Additional manufacture narrative:the customer reseated the l-arm cover, and the system was back to use in good working order.
 
Event Description
It has been reported to philips that after completing a planned procedure, the l-arm rotation cover detached.The cover was retained by its safety chain.No harm has been reported to philips.
 
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Brand Name
ALLURA XPER FD
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 4-6
best 5684 PC
NL  5684 PC
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 4-6
best 5684 PC
NL   5684 PC
Manufacturer Contact
dusty leppert
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key14041693
MDR Text Key288794219
Report Number3003768277-2022-00149
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838054202
UDI-Public00884838054202
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K162859
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
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 NumberALLURA XPER FD20
Device Catalogue Number722028
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/23/2022
Initial Date FDA Received04/07/2022
Date Device Manufactured10/24/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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