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

Model Number 3085

Device Problems Component Falling (1105); Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 12/05/2017

Event Type  malfunction  

Event Description

Head attachment to the operating room table suddenly released and fell down during a case.The certified registered nurse anesthetist (crna) had to hold the patient's head up.Manufacturer response for or table, (per site reporter).Service rep examined the table and could not reproduce the failure.He could not find anything wrong with the device.

Event Description

Head attachment to the operating room table suddenly released and fell down during a case.The certified registered nurse anesthetist (crna) had to hold the patient's head up.Manufacturer response for operating room table, (per site reporter).Service rep examined the table and could not reproduce the failure.He could not find anything wrong with the device.

• Brand Name: AMSCO
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): STERIS; 5960 heisley rd.; mentor OH 44060
• MDR Report Key: 7211800
• MDR Text Key: 97970171
• Report Number: 7211800
• 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,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3085
• 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: 01/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2018
• 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