OAKWORKS MEDICAL CFPM 400 IMAGING TABLE CFPM400 75204-T01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for OAKWORKS MEDICAL CFPM 400 IMAGING TABLE CFPM400 75204-T01 manufactured by Oakworks, Inc..

MAUDE Entry Details

• Report Number: 2529571-2020-00001
• MDR Report Key: 9842387
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2020-03-17
• Date of Report: 2020-03-02
• Date of Event: 2015-08-10
• Date Mfgr Received: 2015-08-10
• Device Manufacturer Date: 2015-06-30
• Date Added to Maude: 2020-03-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. STEPHEN MCKINLEY
• Manufacturer Street: 923 EAST WELLSPRING RD.
• Manufacturer City: NEW FREEDOM PA 17349
• Manufacturer Country: US
• Manufacturer Postal: 17349
• Manufacturer Phone: 7172356807
• Manufacturer G1: OAKWORKS INC.
• Manufacturer Street: 923 EAST WELLSPRING RD.
• Manufacturer City: NEW FREEDOM PA 17349
• Manufacturer Country: US
• Manufacturer Postal Code: 17349
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OAKWORKS MEDICAL CFPM 400 IMAGING TABLE
• Generic Name: CFPM 400 IMAGING TABLE
• Product Code: IXR
• Date Received: 2020-03-17
• Model Number: CFPM400
• Catalog Number: 75204-T01
• Lot Number: N/A
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OAKWORKS, INC.
• Manufacturer Address: 923 EAST WELLSPRING RD. NEW FREEDOM PA 17349 US 17349

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-17