MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 6TH GENERATION WARMING CABINET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the warming cabinet.The technician identified a "sharp" edge on one of the unit's door handles that could have resulted in the reported injured.The technician replaced the door handle, tested the function and operation of the unit, confirmed it to be operating according to specification, and returned it to service.The unit's device history record (dhr) was reviewed by steris quality and no abnormalities were identified.During the final inspection process, no "sharp" edges or burrs were identified.A 3-year complaint review indicates this to be an isolated event and no additional issues have been reported.

Event Description

The user facility reported that an employee obtained a cut upon contacting the door handle on their 6th generation warming cabinet.The employee sought and received medical treatment and returned to work.

• Brand Name: 6TH GENERATION 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: 8112904
• MDR Text Key: 128953188
• Report Number: 1043572-2018-00097
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2018
• 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