DUO HEADLIGHT AND CARRYING CASE
Received Jun 7, 2023 · Event occurred Apr 26, 2023
Report 3006697299-2023-00059 · MDR key 17079719
Device
Product problems
- Overheating of Device
- Overheating of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A FACILITY REPORTED THAT THERE WAS A PROBLEM WITH THE DUO HEADLIGHT AND CARRYING CASE (B)(4). THE STAFF REPORTED THAT THE UNIT BEGAN TO EMIT A BURNT SMELL. WHEN THE TECHNICIANS TESTED THE UNIT, THEY COULD NOT GET THE LIGHT TO START AT ALL, ALTHOUGH THE BATTERY SHOWED A FULL CHARGE. THE TECHNICIANS ALSO TRIED CONNECTING THE HEADLIGHT VIA POWER CABLE WITHOUT SUCCESS. THEY SUSPECTED THAT THE PROBLEM WAS IN THE BATTERY AND INDICATED THAT IS WHERE THE SMELL WAS COMING FROM. THE PRODUCT WAS NOT IN CONTACT WITH A PATIENT. NO PATIENT INJURY, DEATH OR SURGICAL DELAY OCCURRED. FINAL USER: (B)(6) HOSPITAL.
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.
Additional Manufacturer Narrative
THE DUO HEADLIGHT AND CARRYING CASE (90600) WAS RETURNED FOR EVALUATION: THE DUO HEADLIGHT WAS RECEIVED IN USED CONDITION. EVALUATION IDENTIFIED THAT THE DUO HEADLIGHT WAS NOT WORKING DUE TO THE HOLSTER. THE BATTERY HOLSTER WAS DEFECTIVE, THE FAN WAS RATTLING; THE CONNECTOR BOARD REQUIRED REPLACEMENT, AND THE BACK GEAR HOUSING WAS CRACKED. THE BATTERY HOLSTER, CONNECTOR BOARD, GEAR BACK HOUSING AND FAN HAVE BEEN REPLACED. FULL FUNCTIONAL TESTS WERE PERFORMED ACCORDING TO MANUFACTURER'S SPECIFICATION. THE ISSUE OF THIS DUO HEADLIGHT HAVING A BURNING SMELL IS MOST LIKELY DUE TO OVERHEATING CAUSED BY DAMAGE TO THE FAN. THE FAN WAS MOST LIKELY DAMAGED DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE REPORTED COMPLAINT WAS CONFIRMED. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.