MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR EQUIPMENT BOOM

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found that the concrete surrounding one of the four anchor bars had failed causing the bar to become dislodged from the ceiling.The remaining three anchor bars remained in place.Prior to installation steris provides the customer with an evaluation and planning overview which discusses the weight requirements of the system, and what is structurally required from the facility.However, it is up to the facility to ensure that these weight requirements can be supported by their concrete structure.The user facility hired a third-party company to repair and reinforce their ceiling brace.After repairs were completed on the ceiling brace, a steris technician reinstalled the harmonyair equipment boom, tested the unit, confirmed it to be operating according to specifications, and returned it to service.A 3-year complaint review determined this to be an isolated occurrence.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure their harmonyair equipment boom dropped roughly 6 inches from the ceiling.The patient was removed from the room and the procedure was postponed.No report of injury.

• Brand Name: HARMONYAIR EQUIPMENT BOOM
• Type of Device: HARMONYAIR EQUIPMENT BOOM
• 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: 10622825
• MDR Text Key: 213921713
• Report Number: 1043572-2020-00044
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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: 09/02/2020
• 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