FDA Adverse Event Malfunction Summary report: N

S8

MDR report key: 1656640 · Received March 30, 2010

Report

Report Number
1656640
Event Type
Malfunction
Date Received
March 30, 2010
Date of Event
March 2, 2010
Report Date
March 30, 2010
Manufacturer
RESMED CORPORATION
Product Code
BZD
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

PATIENT'S CPAP MACHINE WAS TURNED ON BUT THE PATIENT HAD TAKEN OFF HER MASK AND HEAD GEAR TO GO TO THE BATHROOM. HER ROOMMATE NOTICED A SMALL FIRE AT THE BACK OF THE UNIT. THEY PLACED A BLANKET OVER THE DEVICE TO SMOTHER THE FIRE. THE FIRE DEPARTMENT WAS NOT NOTIFIED AS THE FIRE WAS QUICKLY EXTINGUISHED.WHEN THE HEALTH CARE FACILITY WAS NOTIFIED A FEW DAYS AFTER THE EVENT TOOK PLACE, AN EMPLOYEE WENT TO THE PATIENT'S APARTMENT AND TOOK SEVERAL PHOTOGRAPHS, HOWEVER THE PATIENT REFUSED TO RELINQUISH THE DEVICE. THERE WAS SOOT ON THE BACK OF THE UNIT NEAR WHERE THE AC CORD CONNECTS - THERE WAS SOME MELTED PLASTIC. THERE WAS SOME BLACK MARKS ON THE TABLE BENEATH THE DEVICE. THE TUBING, HEADGEAR AND MASK WERE EXAMINED AND THERE WAS NO EVIDENCE OF SMOKE, HEAT OR FIRE DAMAGE.A NEW DEVICE (DIFFERENT MANUFACTURER) WAS PROVIDED TO THE PATIENT (AT NO CHARGE), WHEN WE FOUND OUR ABOUT THE EVENT, WITH NEW MASK, HEADGEAR AND TUBING.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THERE WAS A KNOWN VOLUNTARY RECALL ON THIS PARTICULAR UNIT / MODEL # FOR A SHORT CIRCUIT IN THE POWER SUPPLY (WITH SOME REPORTS OF MINOR THERMAL DAMAGE), HOWEVER THIS PARTICULAR UNIT HAD NOT BEEN IDENTIFIED AS PART OF THE RECALL. THE UNIT HAD BEEN ISSUED TO THE PATIENT TWO YEARS AGO, A FEW DAYS PRIOR TO THE RECALL NOTICE. THE RECALL WAS ISSUED PRIOR TO THIS PATIENT'S UNIT / SERIAL # BEING LOADED INTO THE COMPUTER SYSTEM - SO WHEN THEY SEARCHED FOR AFFECTED SERIAL #'S, THIS PATIENT'S UNIT DID NOT COME UP.====================== MANUFACTURER RESPONSE FOR CPAP FOR HOME USE======================REQUESTED THAT THE PATIENT SEND THE UNIT BACK TO THE MANUFACTURER -PATIENT REFUSED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 S8 CPAP FOR HOME USE BZD RESMED CORPORATION 33007 *

Patients

Seq Age Sex Outcome Treatment
1 58 YR NO OTHER THERAPIES