DUO HEADLIGHT 2 BAY SYSTEM - US
Received Dec 2, 2021
Report 3006697299-2021-00059 · MDR key 12917892
Device
Generic name
Pfm05
Manufacturer
Integra Lifesciences (ireland) Ltd.Model number
90620USCatalog number
90620US
Lot number
L002214
Product problems
- Intermittent Loss of Power
- Intermittent Loss of Power
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE WEARING THE DUO HEADLIGHT (90620US) DURING A CASE, IT WOULD STOP WORKING AND THEN START WORKING AGAIN. IT WAS SUSPECTED THAT THE UNIT HAD A SHORT IN THE WIRE, AS THERE WAS PERIODIC INTERRUPTIONS IN THE LIGHT BEING ON. AS A RESULT, THERE WAS A DELAY OF APPROXIMATELY FIVE (5) MINUTES, LONG ENOUGH TO FIND A REPLACEMENT. THE PATIENT OUTCOME WAS NOT CHANGED; THE OUTCOME WENT AS EXPECTED. NO PATIENT INJURY OR DEATH WAS REPORTED.
Additional Manufacturer Narrative
THE DUO HEADLIGHT (90620US) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION: FAILURE ANALYSIS: EVALUATION OF THE DUO HEADLIGHT FOUND THAT THE POWER CORD HAD A SHORT AT THE END OF THE CORD THAT CAUSED THE LIGHT TO FLICKER OFF/ON WHENEVER THE CORD WAS MOVED. THE POWER CORD WAS REPLACED TO CORRECT THIS ISSUE. ROOT CAUSE ANALYSIS: EVALUATION IDENTIFIED DAMAGE TO THE POWER CORD DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE REPORTED COMPLAINT WAS 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.