inforMED
MalfunctionFSR

DUO HEADLIGHT 2 BAY SYSTEM - US

Received Dec 16, 2021

Report 3006697299-2021-00071 · MDR key 13020546

Device

Generic name

Pfm05

Model number

90620US

Catalog 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 DUO HEADLIGHT (90620US) WAS RECEIVED BY THE MANUFACTURER¿S SERVICE AND REPAIR DEPOT: FAILURE ANALYSIS: THE DEPOT TECHNICIAN ASSESSMENT FOUND THAT THE FAN INSIDE THE UNIT SHUTS OFF/ON WHENEVER THE END OF THE POWER CORD WAS MOVED, INDICATING A SHORT AT THE END OF THE CORD. THE POWER CORD WAS REPLACED TO CORRECT THIS ISSUE. NO OTHER ISSUES WERE FOUND WITH THIS LOANER UNIT. ROOT CAUSE ANALYSIS: THE RETURNED DUO HEADLIGHT WAS RECEIVED IN USED CONDITION WITH A SHORTED POWER CABLE DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE REPORTED COMPLAINT WAS CONFIRMED. NO FURTHER INVESTIGATION IS REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Description of Event or Problem

IT WAS REPORTED THAT POOL EVALUATION OF THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS NEEDED. NO SPECIFIC FAULT WAS REPORTED. IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED. AFTER THE DEVICE WAS RETURNED BY THE CUSTOMER, EVALUATION INDICATES THAT THERE WAS A SHORT AT THE END OF THE POWER CORD.

Description of Event or Problem

IT WAS REPORTED THAT POOL EVALUATION OF THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS NEEDED. NO SPECIFIC FAULT WAS REPORTED. IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED. AFTER THE DEVICE WAS RETURNED BY THE CUSTOMER, EVALUATION INDICATES THAT THERE WAS A SHORT AT THE END OF THE POWER CORD.

Additional Manufacturer Narrative

THE DUO HEADLIGHT (90620US) WAS RECEIVED BY THE MANUFACTURER¿S SERVICE AND REPAIR DEPOT: FAILURE ANALYSIS: THE DEPOT TECHNICIAN ASSESSMENT FOUND THAT THE FAN INSIDE THE UNIT SHUTS OFF/ON WHENEVER THE END OF THE POWER CORD WAS MOVED, INDICATING A SHORT AT THE END OF THE CORD. THE POWER CORD WAS REPLACED TO CORRECT THIS ISSUE. NO OTHER ISSUES WERE FOUND WITH THIS LOANER UNIT. ROOT CAUSE ANALYSIS: THE RETURNED DUO HEADLIGHT WAS RECEIVED IN USED CONDITION WITH A SHORTED POWER CABLE DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE REPORTED COMPLAINT WAS CONFIRMED. NO FURTHER INVESTIGATION IS REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.