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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OAKWORKS, INC., OAKWORKS MEDICAL CFPM 401 IMAGING TABLE
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OAKWORKS, INC., OAKWORKS MEDICAL CFPM 401 IMAGING TABLE Back to Search Results
Model Number CFPM 401
Device Problem Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 08/14/2014
Event Type  malfunction  
Manufacturer Narrative
Not returned.
 
Event Description
The complaint was received by oakworks, inc., by a customer in (b)(6).The physician had visited an oakworks, inc., booth at a trade show.He explained that he had trialed a cfpm 401 imaging table and wanted to provide feedback.There was no patient involvement and no procedure.He merely showed the oakworks, inc.Representative on the table in the booth at the trade show that the food pedal can slip under the table, causing one of the power motions to be activated.
 
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Brand Name
OAKWORKS MEDICAL CFPM 401 IMAGING TABLE
Type of Device
IMAGING TABLE
Manufacturer (Section D)
OAKWORKS, INC.,
923 east wellspring rd
new freedom PA 17349
Manufacturer (Section G)
OAKWORKS, INC.,
923 east wellspring rd
new freedom PA 17349
Manufacturer Contact
stephen mckinley
923 east wellspring rd
new freedom, PA 17349
7177593087
MDR Report Key6659962
MDR Text Key78451962
Report Number2529571-2017-00001
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCFPM 401
Device Catalogue Number75206-T01
Device Lot NumberNOT LISTED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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