MAUDE Adverse Event Report: OAKWORKS, INC., OAKWORKS MEDICAL CFPM 300 IMAGING TABLE

Model Number CFPM 300

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2016

Event Type  malfunction  

Event Description

The end user damaged the foot control.It happened at the end of the day when they were closing up the room.A staff member used the hand control to lower the table not realizing the foot control was under the column and crushed the foot control.There was no patient involvement.

• Brand Name: OAKWORKS MEDICAL CFPM 300 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
• MDR Report Key: 6660073
• MDR Text Key: 78191864
• Report Number: 2529571-2017-00011
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CFPM 300
• Device Catalogue Number: 75208-T01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1