MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM

Device Problem Device Fell (4014)

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

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and found that the cover had been damaged.This is indicative of facility personnel bumping the lighthead into other pieces of equipment.The operator manual states (1-4), "do not bump light heads into walls or other equipment." the technician replaced the broken cover, tested the lighting system, confirmed it was operating according to specification, and returned it to service.A steris account manager provided an in-service training regarding the proper use and operation of the harmonyair m-series surgical lighting system, specifically avoiding collision with walls or other equipment in the room.No additional issues have been reported.

Event Description

The user facility reported that their harmonyair m-series surgical lighting system cover fell onto the draped lower region of a patient during a procedure, entering the sterile field.A procedure delay occurred as the sterile field was re-established.The procedure was completed successfully.No report of injury.

• Brand Name: HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM
• Type of Device: LIGHTING 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: 10652708
• MDR Text Key: 241076761
• Report Number: 1043572-2020-00048
• Device Sequence Number: 1
• Product Code: FSY
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/12/2020
• Initial Date FDA Received: 10/08/2020
• 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