inforMED
MalfunctionFSR

LED HEADLIGHT ONLY

Received Jul 22, 2022

Report 3006697299-2022-00104 · MDR key 15084284

Device

Generic name

Lighting

Model number

90500

Catalog number

90500

Product problems

  • Overheating of Device
  • Unexpected Shutdown
  • Overheating of Device
  • Unexpected Shutdown

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE LED HEADLIGHT ONLY (90500) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: EVALUATION OF THE LED HEADLIGHT FOUND THAT THE LUMINAIRE GETS REALLY HOT; ADDITIONALLY, THE UNIT HAD A BROKEN MODULE AND REAR COVER. ALL PARTS ARE TO BE REPLACED AS PER ESTIMATE TO BRING UNIT BACK TO MANUFACTURER'S SPECIFICATIONS. ROOT CAUSE ANALYSIS: THE RETURNED LED HEADLIGHT WAS IN USED CONDITION WITH DAMAGE TO THE MODULE AND REAR COVER DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THIS MOST LIKELY LEAD TO THE FAN WORKING SUB-OPTIMALLY AND CAUSED THE DEVICE TO OVERHEAT. THE REPORTED COMPLAINT WAS CONFIRMED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

Description of Event or Problem

A FACILITY REPORTED THAT THE LED HEADLIGHT ONLY (90500) WAS OVERHEATING AND SWITCHING ITSELF OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY IN SURGERY WAS REPORTED.