MAUDE Adverse Event Report: OAKWORKS, INC., OAKWORKS MEDICAL CFPM 400 IMAGING TABLE

Model Number CFPM 400

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2015

Event Type  malfunction  

Manufacturer Narrative

Recurring issue.

Event Description

The end user clinic is having problems with the foot control.When they walk around the table, they are kicking the foot control up under the lower frame and the up function is engaging with the patient on the table.The nurses are aware that this can and does happen.They were advised to unplug the foot pedal and use only the hand control.The customer stated that no patient harm had occurred as they were aware of what caused the movement of the table and were able to react quickly.

• Brand Name: OAKWORKS MEDICAL CFPM 400 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: 6660011
• MDR Text Key: 78192329
• Report Number: 2529571-2017-00006
• 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: health professional
• Reporter Occupation: Health Professional
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CFPM 400
• Device Catalogue Number: 75204-T01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2013
• 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