MAUDE Adverse Event Report: MIDMARK CORP. MIDMARK; PROCEDURE TABLE

Model Number 630-012

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Midmark received the unit and continues investigation.No root cause has yet been determined.Midmark will provide further update upon conclusion of investigation or verification of root cause.

Event Description

Patient seated on the table.Tilt actuator broke causing the head end of the table to fall toward floor.No injuries reported.

• Brand Name: MIDMARK
• Type of Device: PROCEDURE TABLE
• Manufacturer (Section D): MIDMARK CORP.; versailles OH
• Manufacturer Contact: jane carroll ; 60 vista dr.; versailles, OH 45380 ; 9375268604
• MDR Report Key: 4990316
• MDR Text Key: 24692734
• Report Number: 1523530-2015-00006
• Device Sequence Number: 1
• Product Code: GDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Not Applicable
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630-012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2015
• Date Device Manufactured: 03/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1