MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY AMSCO WARMING CABINET

Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the after placing an item on the shelf to their warming cabinet, the shelf fell and contacted an employee's arm resulting in scrape.The employee did not seek or receive medical treatment.
Additional Manufacturer Narrative
The unit subject of the reported event will be returned to montgomery for evaluation.Steris is working to provide the customer a new unit.A follow-up mdr will be submitted once additional information becomes available.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the warming cabinet and identified a difference in measurement of the inside lower compartment.The warming cabinet was returned to steris montgomery for evaluation.The evaluation identified a bracket being out of tolerance (too wide) which allowed the reported event to occur.No similar complaints involving a report of injury have occurred.Steris will continue to monitor post-market data to ensure this remains an isolated event.The user facility was provided a new warming cabinet.No additional issues have been reported.

• Brand Name: AMSCO WARMING CABINET
• Common Device Name: WARMING CABINET
• 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: 19144932
• Report Number: 1043572-2024-00024
• Device Sequence Number: 7960445
• Product Code: LGZ
• UDI-Device Identifier: 00724995154035
• UDI-Public: 00724995154035
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown