DUO HEADLIGHT AND CARRYING CASE
Received Jun 23, 2024
Report 3006697299-2024-00086 · MDR key 19591847
Device
Product problems
- Overheating of Device
- Connection Problem
- Overheating of Device
- Connection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DUO HEADLIGHT AND CARRYING CASE (90600) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: THE DUO HEADLIGHT WAS RECEIVED IN USED CONDITION. EVALUATION WAS ABLE TO CONFIRM THE PROBLEM INDICATED BY THE CUSTOMER. THE DEPOT TECHNICIAN IDENTIFIED THAT THE BATTERY-TO-HEADLIGHT CABLE WAS DEFECTIVE, THE GEAR HOUSING WAS CRACKED, THE LUMINAIRE SUSPENSION LINKAGE SCREWS WERE LOOSE AND THE LUMINAIRE REQUIRED REPLACEMENT. ALL AFOREMENTIONED PARTS WERE REPLACED TO ADDRESS THESE ISSUES. FULL FUNCTIONAL TEST ACCORDING TO MANUFACTURER'S SPECIFICATION HAVE BEEN PERFORMED. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. SEVERAL PARTS NEEDED REPLACEMENT. THIS WAS MOST LIKELY DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.
Description of Event or Problem
IT WAS REPORTED THAT THE CONNECTION BETWEEN THE GREY HOLSTER AND THE HEADLIGHT/DUO HEADLIGHT AND CARRYING CASE (90600) DOES NOT WORK. IT WAS SUBSEQUENTLY REPORTED THAT THE DUO BURNED SOME CABLES. NO PATIENT IMPACT OCCURRED.