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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE PHILIPS; FLUOROSCOPIC XRAY SYSTEM FD20
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PHILIPS HEALTHCARE PHILIPS; FLUOROSCOPIC XRAY SYSTEM FD20 Back to Search Results
Model Number FD20
Device Problem Use of Incorrect Control/Treatment Settings (1126)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2016
Event Type  Injury  
Event Description
Patient in operating room for mitral valve surgery.The operation room table locked and staff was unable to release or move.As a result, the patient was unable to be placed into a trendelenburg position requiring additional monitoring and intervention.Believed emergency stop button on philips xray machine had been inadvertently pushed and this disabled all of the controls on the integrated maquet operating table.Staff present was not aware of this possibility or how to troubleshoot this failure.Appears emergency stop button on philips machine can be inadvertently pushed easily.
 
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Brand Name
PHILIPS
Type of Device
FLUOROSCOPIC XRAY SYSTEM FD20
Manufacturer (Section D)
PHILIPS HEALTHCARE
la palma CA
MDR Report Key5466071
MDR Text Key39325105
Report Number5466071
Device Sequence Number1
Product Code JAA
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 02/19/2016,02/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFD20
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/19/2016
Distributor Facility Aware Date02/04/2016
Device Age3 MO
Event Location Hospital
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 Age47 YR
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