MAUDE Adverse Event Report: STERIS CORPORATION AMSCO 3085-SP; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 3085-SP

Device Problems Self-Activation or Keying (1557); Positioning Problem (3009)

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

Event Date 04/14/2016

Event Type  malfunction  

Event Description

Towards the end of the procedure, the surgeon asked the crna to lower the operating room table down.The foot of the table started to rise.The electrical plug was immediately removed from the bed.The bed continued to fold tilting to the left.The patient was quickly moved to a bed, without injury.

• Brand Name: AMSCO 3085-SP
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley road; mentor OH 44060
• MDR Report Key: 5684565
• MDR Text Key: 46082651
• Report Number: 5684565
• 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: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3085-SP
• Device Catalogue Number: 403516541
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2016
• 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: 23 YR
• Patient Weight: 71