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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 Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2023
Event Type  malfunction  
Event Description
It was reported to philips that smoke came out from the m-cabinet of the allura system.The device was outside of clinical use at the time of the reported event.No harm was reported to philips.Philips has started an investigation of this complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.The philips field service engineer (fse) the system onsite and confirmed that smell of burning occurred, smoke development, the smoke detector has gone off, and the fire brigade was on site at night.Fse examined for traces of a short circuit, defective components, fuses, contactors, capacitors, resistors, circuit boards were tested, and no abnormalities detected.Fse read the system log file and found that system was switched off at the time of the alarm.Fse checked system for functionality and the system works without errors, no visible signs of a malfunction.The device was confirmed to be operating per specifications and no failure was identified.At the time this complaint was received, philips did not have enough information to exclude a product malfunction with the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received which has led to the determination that there was no malfunction of the system.Fse checked system for functionality and the system works without errors, no malfunction of the system was identified.Based on the investigation results, philips concluded that the complaint is not reportable.The codes were updated based on the investigation outcome.
 
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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 6
best 5684 PC
NL  5684 PC
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 6
best 5684 PC
NL   5684 PC
Manufacturer Contact
dusty leppert
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key17735270
MDR Text Key323250075
Report Number3003768277-2023-04988
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838059054
UDI-Public00884838059054
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K130638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
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 Number722012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/30/2023
Initial Date FDA Received09/13/2023
Supplement Dates Manufacturer Received12/22/2023
Supplement Dates FDA Received01/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2013
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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