MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 24" WARMING CABINET

Device Problem Component Falling (1105)

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

Event Date 09/30/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The warming cabinet is not under steris contract agreement for maintenance.The unit is maintained by a third-party service provider.The investigation of this event is currently in process.A follow up mdr will be submitted once additional information becomes available.

Event Description

The user facility reported the door on their warming cabinet fell.

Manufacturer Narrative

No report of injury or procedural delay or cancellation.A steris field service technician arrived onsite, inspected the warming cabinet, and identified the weld had been broken near the door hinge.The pivot pin, which allows for the door to open and close, evidenced signs of damage and wear with marks and grooves around the post diameter.It is unknown how the door sustained the reported damage.The technician replaced the door and the door pins, tested the unit, and confirmed it to be operating according to specification.The unit was returned to service and no additional issues have been reported.

• Brand Name: 24" 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5189308
• MDR Text Key: 30283373
• Report Number: 1043572-2015-00109
• 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,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• 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
• Date Manufacturer Received: 09/30/2015
• 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