MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY UNKNOWN; SURGICAL TABLE

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

The subject medwatch # (b)(4) did not provide a specific surgical table or serial number.Steris has made multiple attempts to contact the initial reporter listed on medwatch # (b)(4) however, no response has been received.Without the inspection of the subject device, a root cause cannot be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.

Event Description

The user facility reported via medwatch # (b)(4) that, "anesthesia was moving the bed to reverse trendelenburg per doctor's request.The bed was slowly moving, and suddenly dropped to a steep reverse trendelenburg.Called for help.Patient was checked under drapes, no visible injuries".

• Brand Name: UNKNOWN
• Type of Device: SURGICAL TABLE
• 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
• MDR Report Key: 18022426
• MDR Text Key: 327753272
• Report Number: 1043572-2023-00155
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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