DUO HEADLIGHT 2 BAY SYSTEM - US
Received Oct 12, 2021
Report 2523190-2021-00221 · MDR key 12619465
Device
Generic name
Pfm05
Catalog number
90620US
Product problems
- Electrical Shorting
- Electrical Shorting
Patient
Not reported
- 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 LUMINAIRE OF THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) HAS A SHORT IN IT. IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.
Additional Manufacturer Narrative
DUO HEADLIGHT (90620US) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS: THE TIE WRAP ON THE GROMMET IS DETACH FROM THE HEADSET; A NEW TIE WRAP HAS BEEN INSTALLED ON THE GROMMET TO CORRECT THIS ISSUE. NO OTHER ISSUES WERE FOUND WITH THIS UNIT. ROOT CAUSE: THE RETURNED 90620US HEADLIGHT IS IN USED CONDITION WITH DAMAGE TO THE CABLE TIE WRAP DUE TO ROUGH HANDLING OR ENVIRONMENTAL DAMAGE. THE REPORTED COMPLAINT IS CONFIRMED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.
Description of Event or Problem
N/A.