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 07/24/2017

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 called; they received the advisory notice regarding the foot control field action.The customer would like a new foot control along with the retrofit kit of the field action.Their foot control has already gotten lodged under table and was cracked, so they need a new foot control too.

• 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 17439
• 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: 9842822
• MDR Text Key: 207962993
• Report Number: 2529571-2020-00003
• 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: Physician
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2017
• 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