DUO HEADLIGHT 2 BAY SYSTEM - US

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 DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) FAN WAS NOT WORKING AND OVERHEATING MAKING THE LIGHT TO FLICKER. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THE DEVICE FAILURE LED TO PATIENT INJURY OR SURGICAL DELAY.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

UPDATED FIELDS: D9, G3, G6,H2, H3, H6, H11. THE DEVICE DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS: THE 90620US DUO HEADLIGHT WAS RECEIVED IN USED CONDITION. THE EVALUATION IDENTIFIED THAT THE HEADLIGHT POWER CORD CONNECTOR IS SHORT-CIRCUITED AND THE HOLSTER IS DAMAGED. THE ISSUE OF A "SHORT" REFERS TO A 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. THIS IS MOST LIKELY DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE REPORTED COMPLAINT IS CONFIRMED. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. EVALUATION IDENTIFIED THAT THE HEADLIGHT POWER CORD CONNECTOR IS SHORT-CIRCUITED, AND THE HOLSTER IS DAMAGED. THE ISSUE OF A SHORT REFERS TO A 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.