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

Model Number CFPM 300

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

An internal process audit finding created a task for par #5 (preventative action recommendation) from capa (b)(4) to review the complaint data and retrospectively report any previously unreported complaints associated with field action recall #z-0703-2018.Four complaints were found during the review that meet the criteria which are being reported.

Event Description

Customer reported that the up button on the foot control is sticking and causing the table to continue to raise after they release the button.Customer had damaged the foot control by lowering the column onto it.No patient involvement or adverse event reported.

• 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 17249 ; 7172356807
• MDR Report Key: 9842813
• MDR Text Key: 207960613
• Report Number: 2529571-2020-00002
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1