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

Device Problem Device Fell (4014)

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

Prior to the reported event, the user facility's biomed department contacted steris stating that their lightheads were loose.A steris technician advised the user facility to stop using the lighting system until a formal inspection could be completed however, the user facility continued to use the lighting system.A steris service technician arrived onsite following the reported event to inspect the lighting system and found that the retaining ring that secures the lighthead to the suspension system was not fully seated.As the retaining ring was not fully seated, this allowed for the lighthead to loosen from its connection point and eventually detach from the suspension system resulting in the reported event.The technician made the necessary repairs, tested the unit, confirmed it was operating according to specification and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that prior to the start of a patient procedure user facility personnel moved their harmony air e-series surgical lighting system causing the lightheads to fall from their yoke covers.User facility personnel moved the patient to another room to complete the procedure and the procedure was completed successfully.No report of injury.

• Brand Name: HARMONYAIR E-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: 11970231
• MDR Text Key: 260467520
• Report Number: 1043572-2021-00041
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/09/2021
• 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