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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE MULTIDIAGNOST ELEVA SYSTEM, X-RAY, STATIONARY

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PHILIPS HEALTHCARE MULTIDIAGNOST ELEVA SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number 708037
Device Problem No Display/Image (1183)
Patient Problem Radiation Overdose (1510)
Event Type  malfunction  
Manufacturer Narrative
When the investigation has been completed philips will inform the fda.
 
Event Description
Philips has received through the medicines and healthcare products regulatory agency an adverse incident report submitted by the (b)(6) hospital (incident number 2019/012/009/401/005). In this report it was reported: apparent over exposure during musculoskeletal procedures (msk) fluoroscopy of the shoulder (70kv at 300 ma and dap reading of 14. 9cgycm2 - normal dap approx. 5 cgycm2) resulting in very bright image and loss of image detail. Examination was abandoned. Philips has initiated an investigation of this complaint.
 
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Brand NameMULTIDIAGNOST ELEVA
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
p.o. box 10.000
best 5680 DA
NL 5680 DA
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
dusty leppert
veenpluis 4-6
p.o. box 10.000
best 5680 -DA
NL   5680 DA
MDR Report Key9488299
MDR Text Key181522492
Report Number3003768277-2019-00104
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K050151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number708037
Device Catalogue Number708037
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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