DUO HEADLIGHT 2 BAY SYSTEM - US
Received Apr 3, 2023 · Event occurred Mar 9, 2023
Report 3006697299-2023-00034 · MDR key 16664715
Device
Generic name
Pfm05
Manufacturer
Integra Lifesciences (ireland) Ltd.Model number
90620USCatalog number
90620US
Product problems
- Electrical Shorting
- Electrical Shorting
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE REPORTED DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND A DEFINITE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. BASED ON THE REPORTED COMPLAINT, THE PROBABLE ROOT CAUSE FOR THIS 90620US HEADLIGHT HAVING A SHORT IN THE CORD FROM THE HEADBAND TO THE BATTERY PACK IS DAMAGE TO THE CORD CAUSED BY ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE ISSUE OF A "SHORT" REFERS TO POOR CONNECTION OF THE POWER PINS THAT CAN POTENTIALLY RESULT IN A FAILING CONNECTION TO THE BATTERY PORT. NO RISK OF HARM WOULD BE INCURRED BY THIS TYPE OF SHORT, AND THE LOW VOLTAGE WOULD NOT CAUSE A HAZARD. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
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 CORD LEADING TO THE BATTERY PACK OF THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) HAS A SHORT IN IT. NO PATIENT/USER INJURY, DEATH OR SURGICAL DELAY OCCURRED AS A RESULT OF THE EVENT.