MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY AMSCO LD202 IN-CEILING LIGHTING SYSTEM

Model Number LD202

Device Problem Smoking (1585)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and found the orbis lighthead board assembly to be burned and was emitting the smell of smoke.The technician replaced the lighthead board assembly, tested the lighting system, confirmed it to be operating 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.

Event Description

The user facility reported that prior to the start of a patient procedure smoke was observed emitting from their amsco ld202 in-ceiling lighting system.The patient was transferred to a different room and the procedure was completed successfully.No report of injury or procedure delay.

• Brand Name: AMSCO LD202 IN-CEILING 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: 15852524
• MDR Text Key: 304412885
• Report Number: 1043572-2022-00085
• Device Sequence Number: 1
• Product Code: KZF
• UDI-Device Identifier: 00724995161286
• UDI-Public: 00724995161286
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LD202
• Device Catalogue Number: P141211221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2018
• 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