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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; Computer Operating System Problem
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 NamePHILIPS MEDICAL SYSTEM
Type of DeviceX-RAY, R&F ROOM, CARDIO
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
lakewood CO 80401
MDR Report Key8869999
Report Number8869999
Device Sequence Number1
Product CodeLLZ
Report Source User Facility
Reporter Occupation
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?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/31/2019 Patient Sequence Number: 1
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