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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS MEDICAL SYSTEM; X-RAY, R&F ROOM, CARDIO

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PHILIPS MEDICAL SYSTEMS PHILIPS MEDICAL SYSTEM; X-RAY, R&F ROOM, CARDIO Back to Search Results
Model Number ALLURA XPER FD20
Device Problems Device Inoperable (1663); Computer Operating System Problem (2898)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 07/23/2019
Event Type  Injury  
Event Description
Er called an ami.Pt was brought to lab and loaded onto table.Pt was cleaned and draped per protocol.Arterial sheath was placed.When tech tried to guide c-arm into place to obtain images of arteries the c-arm did not work.Tech ran to back and rebooted machine in attempt to correct error.Machine came back up with same error message.Physician decided it was best interest of pt to care flight to a higher level of care facility to finish heart cath.Biomed and appropriate parties were notified.
 
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Brand Name
PHILIPS MEDICAL SYSTEM
Type of Device
X-RAY, R&F ROOM, CARDIO
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
lakewood CO 80401
MDR Report Key8869999
MDR Text Key153700034
Report Number8869999
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberALLURA XPER FD20
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/28/2019
Distributor Facility Aware Date07/23/2019
Event Location Other
Date Report to Manufacturer07/28/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
Patient Weight91
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