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

Model Number CFPM 400

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2015

Event Type  malfunction  

Event Description

The customer lowered the column onto the foot pedal and damaged the foot pedal.There was no patient involvement.

• 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: 6660021
• MDR Text Key: 78192449
• Report Number: 2529571-2017-00009
• 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: distributor
• Reporter Occupation: Biomedical Engineer
• 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: Biomedical Engineer
• 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: 10/29/2015
• Initial Date FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1