MAUDE Adverse Event Report: SKYTRON, LLC; TABLE, OPERATING-ROOM, ELECTRICAL

Device Problems Material Separation (1562); Protective Measures Problem (3015)

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

Event Date 06/08/2017

Event Type  malfunction  

Event Description

Operating room table was put into steep trendelenburg position, causing safety brackets on bed to disengage part of the table.Patient slid toward anesthesia about 4-5 inches, was immediately noticed and caught/supported by operating room staff and safely repositioned on bed.No injury was noted at this time. case was converted to open due to inability to position patient safely in trendelenburg.Patient was reprepped, redraped, and case continued.

• Type of Device: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): SKYTRON, LLC; 5085 corporate exchange blvd se; grand rapids MI 49512
• MDR Report Key: 6910954
• MDR Text Key: 88044881
• Report Number: 6910954
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• 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: 08/04/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR