DUO HEADLIGHT 2 BAY SYSTEM - US
Received Nov 17, 2022
Report 3006697299-2022-00155 · MDR key 15817385
Device
Generic name
Pfm05
Manufacturer
Integra Lifesciences (ireland) Ltd.Model number
90620USCatalog number
90620US
Product problems
- Overheating of Device
- Overheating of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
A FACILITY REPORTED THAT THE LIGHT OF THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS GETTING TOO HOT. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER. NO INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.
Additional Manufacturer Narrative
EVALUATION OF THE RETURNED DUO HEADLIGHT 2 BAY SYSTEM (90620US) COULD NOT DUPLICATE ANY ISSUES WITH THIS UNIT OVERHEATING. THE PROBABLE ROOT CAUSE OF THIS DUO HEADLIGHT OVERHEATING COULD BE DUE TO THE FAN INSIDE THE UNIT NOT FUNCTIONING PROPERLY. HOWEVER, SERVICE AND REPAIR DEPARTMENT COULD NOT FIND ANY ISSUES WITH THIS UNIT, INCLUDING THE FAN. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.