DUO HEADLIGHT 2 BAY SYSTEM - US
Received Jul 7, 2024
Report 3006697299-2024-00098 · MDR key 19686889
Device
Product problems
- Insufficient Heating
- Overheating of Device
- Insufficient Heating
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) FLICKERS DUE TO TOP COOLING FAN NOT WORKING. THE UNIT WOULD OPERATE NORMALLY FOR THE FIRST TEN MINUTES THEN PROCEEDED TO FLICKER WHEN THE MODULE GOT HOT. NO PATIENT INJURY, DEATH OR SURGICAL DELAY HAS BEEN REPORTED.
Additional Manufacturer Narrative
THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - THE DUO HEADLIGHT WAS RECEIVED IN USED CONDITION. EVALUATION IDENTIFIED THAT THE HEADLIGHT POWER CORD CONNECTOR PIN WAS BROKEN OFF. THE POWER CORD HAS BEEN REPLACED TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTS. ROOT CAUSE ANALYSIS - IT WAS DETERMINED THAT THE DAMAGE WAS MOST LIKELY DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.
Additional Manufacturer Narrative
UPDATED FIELDS G3, G6, H2, H11. CORRECTED FIELD: H6 (MEDICAL DEVICE PROBLEM CODE).
Description of Event or Problem
N/A.