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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Model Number ALLURA XPER FD10
Device Problem No Display/Image (1183)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2023
Event Type  malfunction  
Event Description
It was reported to philips that the device was unable to save images from the examination.The device was in clinical use.No harm to the patient or user was reported.Philips has started an investigation of this complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.According to additional information collected the customer was performing a coronary diagnostic procedure which was delayed by 15 minutes and the procedure was completed by using another system.The philips field service engineer (fse) inspected the system onsite and confirmed that the system was unable to save images during examination.A review of the log files also confirmed the reported problem.Upon functional testing, fse confirmed that the bios battery and the hard drive need replacement.To resolve the issue fse replaced the bios battery and the hard drive.After this, the system was returned to use in good working order.The codes were updated based on the investigation outcome.
 
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Brand Name
ALLURA XPER FD10
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
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
derrick massuri
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key18142565
MDR Text Key328228436
Report Number3003768277-2023-06278
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K041949
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 FD10
Device Catalogue Number722003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/06/2023
Initial Date FDA Received11/15/2023
Supplement Dates Manufacturer Received02/02/2024
Supplement Dates FDA Received02/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2006
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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