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

Model Number CFPM 400

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

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 reports they have a cfm 400 c-arm table that has been having an issue where it will continue to go up even when no one is pushing the up button, and usually won't stop until it reaches maximum height.The only way they have been able to stop it is to use the emergency stop button.A review of the foot control photo indicates the cut was on an outside button.This implies the foot control was damaged by contact with the column.

• 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 ; 7172356708
• MDR Report Key: 9843260
• MDR Text Key: 206534076
• Report Number: 2529571-2020-00004
• 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 400
• Device Catalogue Number: 75204-T01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2015
• 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