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

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Bruise/Contusion (1754); Swelling (2091)

Event Date 09/28/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The facility's biomedical technician inspected the door and found the lower bracket that the hinge pin screws into had separated from the door.The biomedical technician temporarily repaired the warming cabinet and contacted steris.A steris service technician inspected the warming cabinet and could not confirm that the biomedical technicians repairs were properly performed, therefore the steris technician replaced the cabinet door assembly and returned the warming cabinet to service.No additional issues have been reported.

Event Description

The user facility reported that an employee opened the lower door of the warming cabinet when the door fell off on the employee's toe.The employee was instructed to go to the facility's er.An x-ray was taken however no broken bones were observed.The employee's toe was bruised and swollen; she returned to work.

• 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: 5170120
• MDR Text Key: 29337448
• Report Number: 1043572-2015-00107
• 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: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• 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: 09/29/2015
• 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