MAUDE Adverse Event Report: SKYTRON LLC HERCULES; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 6702

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 12/13/2019

Event Type  malfunction  

Event Description

Patient was positioned in lithotomy in maquet stirrups on the skytron 6702 cysto table, the table suddenly tilted forwards and the patient slowly slid onto the plastic cysto drape, buttocks was on the floor, legs still in stirrups and safety strap remained in place, however the laryngeal mask airway (lma) was dislodged and had to be replaced.The patient was picked up by staff and placed back on table.

• Brand Name: HERCULES
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): SKYTRON LLC; 5085 corporate exchange blvd se; grand rapids MI 49512
• MDR Report Key: 9551298
• MDR Text Key: 173713708
• Report Number: 9551298
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Weight: 86