MAUDE Adverse Event Report: PRISM MEDICAL TRANSISITON GATE BRACKET MOUNT

Model Number 363980

Device Problem Fail-Safe Problem (2936)

Patient Problem Concussion (2192)

Event Date 03/11/2015

Event Type  Injury  

Event Description

A transition gate bracket mount installed on (b)(6) 2013 and used daily for the last two years was seen with the locking pin stuck in up position, the locking screw on the lock pin was missing, and other signs of wear and tear.It was reported the motor fell off the track and landed on the head of an experienced female employee and the individual suffered a concussion and was placed on extended medical leave.

• Brand Name: TRANSISITON GATE BRACKET MOUNT
• Type of Device: NA
• Manufacturer (Section D): PRISM MEDICAL; maryland heights MO
• Manufacturer Contact: jeff matthews ; 10888 metro ct; maryland heights, MO 63043 ; 3146929135
• MDR Report Key: 4749861
• MDR Text Key: 5769031
• Report Number: 3007802293-2015-00012
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 363980
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XY GANTRY; C450 MOTOR
• Patient Outcome(s): Hospitalization