• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS HEALTHCARE MULTIDIAGNOST ELEVA WITH FLAT SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number 708034
Device Problem Mechanical Problem (1384)
Patient Problems Fall (1848); Injury (2348)
Event Type  malfunction  
Manufacturer Narrative
The investigation conducted by philips concluded that the actuator failed due to loading fatigue of the actuator. Misalignment of the actuator points or hitting an obstacle during table movement contribute to this loading fatigue. The defective parts were replaced and the system is in use now.
 
Manufacturer Narrative
Defective part has been send for investigation to manufacturer. When the investigation has been completed philips will inform the fda.
 
Event Description
Philips received a complaint in which it was reported that the operator was positioning the patient in the trendelenburg position. At some point the system didn't stop moving and it went over 90 degrees. The patient fell of the table, this resulted in a minor injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMULTIDIAGNOST ELEVA WITH FLAT
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 Key7028242
MDR Text Key169733133
Report Number3003768277-2017-00094
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeQA
PMA/PMN Number
K961374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number708034
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 Received10/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-