MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Steris became aware of this event on (b)(6) 2022 through our periodic review of the medsun database.The report did not identify the name or location of the user facility of the device in question.To date we have not been informed of this event directly from the user facility.Should we obtain additional information regarding the user facility or specific device subject of this event, a follow-up report would be filed with the results of our investigation.

Event Description

The user facility reported via user facility medsun report the following, "just prior to prep of surgical site, there was a smell of "something burning".It was noticed there was smoke coming from the electrical outlet on base of or bed.Code red was immediately called, and patient was removed from or bed to stretcher and room was evacuated.Patient transported to another or and placed on anesthesia ventilator.After repositioning the patient on another or bed, case proceeded without incident.".

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15513830
• MDR Text Key: 304414020
• Report Number: 1043572-2022-00063
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 09/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1