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

Model Number 3085

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/07/2019

Event Type  malfunction  

Event Description

Patient was intubated, prepped, and draped all in usual fashion.The procedure was started.Doctor asked certified registered nurse anesthetists (crna) to place the patient in reverse trendelenburg with the right side up.When crna went to move the bed it would not respond or move.All plugs were checked on the bed and the controller was switched with another matching controller along with the cord to the bed.The manual controls on the bed also would not respond.Upon discussion with doctor it was determined that we would have to move the patient to a different bed.A different working bed was brought into the room and the patient was safely transferred to the other bed.

• Brand Name: AMSCO
• Type of Device: TABLE, OPERATING-ROOM
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 9290169
• MDR Text Key: 165446332
• Report Number: 9290169
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2019,10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3085
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2019
• Date Report to Manufacturer: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17155 DA