MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR EQUIPMENT MANAGEMENT SYSTEM

Device Problem Device Emits Odor (1425)

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

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the ems unit subject of the event.While onsite, the technician was informed that a "smoke" odor was emitting from the unit; however, the technician did not find any evidence of smoke damage and was unable to detect the reported odor.The user facility could not confirm that the "smoke" odor originated from the unit as the room contains other pieces of equipment that could have caused the reported event.The steris technician performed a full inspection of the harmonyair ems and was unable to reproduce the reported event.Per the technician's inspection, the unit was found to be operational; no repairs were required.Therefore, the root cause of the reported event does not appear to be attributed to our unit.The harmonyair ems is under steris service agreement for maintenance activities and no additional issues have been reported.

Event Description

The user facility reported that a "smoke" odor was emitting from the harmonyair equipment management system (ems).No report of injury to the staff present in the room.No report of procedure delay or cancellation.The event did not occur during a patient procedure.

• Brand Name: HARMONYAIR EQUIPMENT MANAGEMENT SYSTEM
• Type of Device: MANAGEMENT SYSTEM
• 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: 7687683
• MDR Text Key: 114421487
• Report Number: 1043572-2018-00054
• Device Sequence Number: 1
• Product Code: FQO
• 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: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• 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: 06/14/2018
• 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