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

Model Number A-SERIES LIGHTING SYSTEM

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

The user facility reported the light handle of their harmonyair a-series lighting system is detaching and falling during use.Injuries or procedure delays were reported.

Manufacturer Narrative

A steris field service technician arrived onsite to inspect the lighting system and found the light handle was not properly locking into position when installed on the lighthead resulting in the reported event.The lighting system has been removed from service pending repairs.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported the light handle of their harmonyair a-series lighting system is detaching and falling during use.No injuries or procedure delays were reported.

Manufacturer Narrative

The investigation determined that the light handle locking mechanism was not fully engaged resulting in the reported event.The technician replaced the light handle, tested the unit, confirmed it to be operation according to specifications and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: HARMONYAIR A-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: 16062815
• MDR Text Key: 308458388
• Report Number: 1043572-2022-00094
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-SERIES LIGHTING SYSTEM
• Device Catalogue Number: LAS01IN01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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