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

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmonyair ems and found the shelf on the floor.Through follow-up with facility personnel and observation of other harmonyair ems units at the facility, the technician determined that facility personnel had exceeded the maximum weight for the shelves.The harmonyair ems operator manual states (1-3), "caution - possible equipment damage: small shelf weighs 5.7 lb.(2.6 kg.).Maximum load capacity of small shelf is 44 lb.(20 kg.).Do not overload.Large shelf weighs 18 lb.(8.2 kg.).Maximum load capacity of large shelf is 110 lb.(50 kg.).Do not overload." the technician re-installed the shelf and returned the unit to service.The technician counseled facility personnel on the proper use and operation of their harmonyair ems, specifically to not exceed the weight limits for the shelves.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure, a shelf on their harmonyair ems fell to the floor.No report of injury or procedure delay.

• Brand Name: HARMONYAIR EMS
• Type of Device: EQUIPMENT 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: 8745282
• MDR Text Key: 149797694
• Report Number: 1043572-2019-00049
• 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: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• 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: 05/30/2019
• 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