MAUDE Adverse Event Report: STERIS CORPORATION AMSCO SURGICAL TABLE; TABLE, OPERATING-ROOM, AC POWERED

Model Number 3080-R

Device Problem Mechanical Problem (1384)

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

Event Date 05/07/2018

Event Type  malfunction  

Event Description

The operating room table while in use during a procedure, aggressively returned to supine position after anesthesia attempted to position the operating room table to trendelenburg per the surgeon's request.This event was documented in the organization's incident reporting system.The procedure was completed and the operating room table was taken out of service until a steris biomedical repair person to assess and repair the operating room table.

• Brand Name: AMSCO SURGICAL TABLE
• Type of Device: TABLE, OPERATING-ROOM, AC POWERED
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd.; mentor OH 44060
• MDR Report Key: 8174785
• MDR Text Key: 131134330
• Report Number: MW5082193
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/14/2018

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: Health Professional
• Device Model Number: 3080-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR