• 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 BUCKY DIAGNOST TH 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 MEDICAL SYSTEMS DMC GMBH BUCKY DIAGNOST TH X-RAY, STATIONARY Back to Search Results
Model Number 704030
Device Problem Use of Device Problem (1670)
Patient Problems Bone Fracture(s) (1870); Injury (2348)
Event Date 08/28/2018
Event Type  Injury  
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
The customer complained that due to an operator error, the finger of another operator or bystander was pinched at the telescopic tube arm of the ceiling suspension. The person suffered a fracture of the fingertip, which needed dedicated treatment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBUCKY DIAGNOST TH
Type of DeviceX-RAY, STATIONARY
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 Key7876301
MDR Text Key120247311
Report Number3003768251-2018-00007
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K945278
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 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number704030
Device Catalogue Number704030
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 Received08/30/2018
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

Patient Treatment Data
Date Received: 09/14/2018 Patient Sequence Number: 1
-
-