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

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST SINGLE DETECTOR SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

  • 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 MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST SINGLE DETECTOR SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Model Number 712020
Device Problem Folded (2630)
Patient Problems Abrasion (1689); Hematoma (1884); Injury (2348)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The patient support is an accessory that enables the examination of full leg or full spine, with the patient standing upright. For ease of use, the stand has wheels and a folding footboard. The footboard is connected to the frame via two hinges and has to be folded up and fixed by a hook for transportation, e. G. From one room to another. The investigation revealed that both hinges had fully different signs of wear and tear. The result was that the footboard did not fit properly into the frame and additional pressure was needed to securely lock the hook. The replaced parts (hinges and hook) were sent back for investigation. They were mounted at a patient support in the development department and led to the investigation result. The hook showed no damage and worked as specified. The hinges and the hook were replaced. A capa was initiated and resulted in a remedial action (b)(4). The field remedial action contains improvement of hinges and an additional brake cylinder. Health professional instead of consumer.
 
Manufacturer Narrative
(b)(4). The investigation is still ongoing on this event. When the investigation is completed a follow-up report will be sent to the fda.
 
Event Description
During movement of patient support, the foot support folded down onto nurse shin. Nurse has abrasions and hematoma on both shins. Minor injury occurred.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDIGITALDIAGNOST SINGLE DETECTOR
Type of DeviceSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS DMC GMBH
roentgenstr. 24
hamburg 22335
GM 22335
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
dusty leppert
roentgenstr. 24
hamburg 22335
GM   22335
405078-229
MDR Report Key6979112
MDR Text Key275165553
Report Number3003768251-2017-00007
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K090625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number712020
Device Catalogue Number712020
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 Received10/05/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-