inforMED
MalfunctionHCS

RIGHT ANGLE AIRWAY PRONE

Received Apr 27, 2006 · Event occurred Mar 27, 2006

Report 9611451-2006-00005 · MDR key 704481

Device

Generic name

Temperature Probe

Model number

9600MR561

Catalog number

9600MR561

Lot number

031015

Product problems

  • Alarm, audible
  • Fire
  • Melted
  • Sparking

Patient

*

  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

FISHER AND PAYKEL HEALTHCARE (FPHC) RECEIVED A REPORT FROM CARDINAL HEALTH REGARDING AN ALLEGED FIRE. THE PATIENT HAD BEEN ON A FPHC RT110 BREATHING CIRCUIT FOR ABOUT 24 HOURS. THE HUMIDIFIER WAS THE FPHC MR 370 AND ASSOCIATED ACCESSORIES, WITH MR290 HUMIDIFICATION CHAMBER. THE PATIENT, VENTILATOR, HUMIDIFIER AND CIRCUIT WERE TRANSPORTED TO THE CATH LAB FOR A PROCEDURE. A RESPIRATORY THERAPIST THEN WENT ABOUT HIS/HER DUTIES. DURING THE PROCEDURE ( A PERIOD OF ABOUT 1 HOUR) IT WAS REPORTED THAT THE NURSING STAFF SILENCED THE MR730 ALARMS AT LEAST TWICE . THE CAUSE OF THE ALARMS IS UNKNOWN. THE RESPIRATORY THERAPIST WAS CALLED TO RESPOND TO THE CATH LAB STAT AND UPON ENTERING THE AREA, IMMEDIATELY NOTED THAT THE CIRCUIT WAS APPARENTLY MELTED AND THERE ALLEGEDLY WERE FLAMES AND SPARKS COMING FROM THE RESPIRATORY LIMB AND A PORTION OF THE PATIENT DRAPE. THE RESPIRATORY THERAPIST IMMEIDATELY ASSISTED THE PATIENT SUCTIONING AND PROVIDED APPROPRIATE VENTILATION AND OXYGENATION. THERE IS NO REPORTED INJURY OR CONCERN FOR THE PATIENT AT THIS TIME.