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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ALLURA XPER FD10; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS MEDICAL SYSTEMS ALLURA XPER FD10; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 722026
Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)
Patient Problem Head Injury (1879)
Event Date 05/15/2019
Event Type  malfunction  
Event Description
During a procedure, the corrugated cable from the monitor assembly came unscrewed and the cable fell and hit a nurse on her head (no lacerations or bumps).The nurse reported that at the present time, she was fine; but she stated that did not know how this bump would cause her pain in the days to come.The user left the corrugated cable hanging down and finished the started case.Field service representative was contacted to fix the problem.The field service representative was instructed to use loctite when screwing the corrugated cable back in place.Repair successful with secured cable back in place.
 
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Brand Name
ALLURA XPER FD10
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
595 miner road
cleveland OH 44143
MDR Report Key8639801
MDR Text Key146052205
Report Number8639801
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number722026
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2019
Event Location Hospital
Date Report to Manufacturer05/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age18980 DA
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