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

MAUDE Adverse Event Report: SONESTA MEDICAL AB SONESTA 6202 SERIES IMAGING TABLE TABLE, RADIOGRAPHIC, TILTING

  • 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
 

SONESTA MEDICAL AB SONESTA 6202 SERIES IMAGING TABLE TABLE, RADIOGRAPHIC, TILTING Back to Search Results
Model Number 6202
Device Problem Detachment Of Device Component (1104)
Patient Problem Fall (1848)
Event Date 04/03/2018
Event Type  malfunction  
Event Description
The bolt that holds the motor that powers the table to move up and down at the back of the table came out and the table teetered forward and the patient fell to the ground. Device arrived new to hospital on (b)(6) 2008.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSONESTA 6202 SERIES IMAGING TABLE
Type of DeviceTABLE, RADIOGRAPHIC, TILTING
Manufacturer (Section D)
SONESTA MEDICAL AB
MDR Report Key7464544
MDR Text Key106791534
Report NumberMW5076782
Device Sequence Number0
Product Code IXR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6202
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-