MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY WARMING CABINET

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Following the reported event, the unit was removed from service.A steris service technician arrived onsite to inspect the warming cabinet.The technician identified that the plastic button located on the unit's momentary pushbutton switch required replacement.The pushbutton switch spring made contact with the metal surface of the warming cabinet door which caused an electrical arcing on the warming cabinet door and the reported event to occur.The electrical arcing created enough heat to melt a portion of the plastic control panel.The technician replaced the pushbutton switch and control panel on the warming cabinet, tested the unit, and found it to be operating properly.The unit was returned to service.

Event Description

The user facility reported that a burning odor was emitting from their warming cabinet.No report of injury.

• Brand Name: WARMING CABINET
• Type of Device: 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 ; 4403927453
• MDR Report Key: 7135192
• MDR Text Key: 95960519
• Report Number: 1043572-2017-00085
• Device Sequence Number: 1
• Product Code: LGZ
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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