MAUDE Adverse Event Report: MORGAN MEDESIGN, INC. MORGAN BASIC ONE; TABLE, RADIOLOGIC

Device Problem Collapse (1099)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 02/24/2021

Event Type  malfunction  

Event Description

Staff brought (b)(6) center patient into procedure room and instructed patient how to get on surgical table.The table collapsed to the floor with the patient in/on it.Patient reported he was "fine".Patient called hospital later regarding left shoulder soreness with bruise and neck pain that he noted after fall/collapse of surgical table.

• Brand Name: MORGAN BASIC ONE
• Type of Device: TABLE, RADIOLOGIC
• Manufacturer (Section D): MORGAN MEDESIGN, INC.; 947 piner pl; santa rosa CA 95403
• MDR Report Key: 11824633
• MDR Text Key: 250633843
• Report Number: 11824633
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/10/2021

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2021
• Date Report to Manufacturer: 05/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23360 DA
• Patient Weight: 125