MAUDE Adverse Event Report: STERIS CORPORATION STERIS 4085 SURGICAL TABLE; SURGICAL TABLES

Model Number 4085

Device Problem Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  No Answer Provided  

Event Description

There was an electrical burning smell in operating room (or) at the end of the case, while the patient was still on the operating room table.We unplugged and removed all equipment with the exception of the operating room table and anesthesia machine.When patient left the operating room, we removed the operating room table and smelled the burning from there.Table brought to biomed.No patient harm.Following event, biomed: no issues were found with electrical components.Electrical safety test was performed leakage test and resistance test all passed.Performed functional test of operating room table and no burning smell occurred.

• Brand Name: STERIS 4085 SURGICAL TABLE
• Type of Device: SURGICAL TABLES
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• MDR Report Key: 10337795
• MDR Text Key: 200824522
• Report Number: 10337795
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Model Number: 4085
• 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: 07/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA