inforMED
MalfunctionFSR

DUO HEADLIGHT 2 BAY SYSTEM - US

Received Jul 22, 2022

Report 3006697299-2022-00105 · MDR key 15085750

Device

Generic name

Pfm05

Model number

90620US

Catalog number

90620US

Product problems

  • Electrical Shorting
  • Intermittent Loss of Power
  • Electrical Shorting
  • Intermittent Loss of Power

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: EVALUATION OF THE DUO HEADLIGHT 2 BAY SYSTEM IDENTIFIED DAMAGE TO THE POWER CORD. AFTER REPLACING THE POWER CORD, THE UNIT FAILED THE LIGHT QUALITY TEST WITH ARTIFACTS IN THE LIGHT IMAGE. THE UNIT HOLSTER WAS MISSING A KNOB. THE POWER CORD HAS BEEN REPLACED TO CORRECT THE POWER CORD ISSUE. THE DUO HEADLIGHT WILL NEED TO BE SENT OUT TO THE MANUFACTURER FOR LUMINAIRE REPAIR. ROOT CAUSE ANALYSIS: THE DUO HEADLIGHT WAS IN USED CONDITION WITH DAMAGE TO THE POWER CORD DUE TO ROUGH HANDLING OR ENVIRONMENTAL DAMAGE. THE REPORTED COMPLAINT WAS CONFIRMED. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. 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

A FACILITY REPORTED THAT THE DUO HEADLIGHT (90620US) MAY HAVE A CIRCUIT SHORTING ISSUE; THE LIGHT INTERMITTENTLY FAILS. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER, NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.