FDA Adverse Event Other Summary report: N

HUMIDAIRE 3I-AMERICAS

MDR report key: 1054731 · Received May 29, 2008

Report

Report Number: 3004604967-2008-00007
Event Type: Other
Date Received: May 29, 2008
Date of Event: January 30, 2008
Report Date: May 23, 2008
Manufacturer: RESMED LTD.
Product Code: BTT
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

WE INSPECTED, TESTED AND RAN THE H3I FOR 48 HOURS (OVERNIGHT) AND WE DID THE SAME TO THE S8 WITH NO PROBLEMS FOUND. BOTH UNITS WERE SENT TO RESMED LTD FOR FURTHER INVESTIGATION ALSO DEMONSTRATED BOTH DEVICES FUNCTIONED TO SPECS. UNFORTUNATELY, WE COULDN'T GET THE SWIFT MASK BACK FOR EVALUATION. IN ADDITION, WE TALKED TO THE THERAPIST AND ASKED HER IF SHE ACTUALLY SAW THE WOUND ON THE PATIENT'S LEFT NOSTRIL, SHE SAID NO. AS PER HER, THE PATIENT CALLED AND TOLD HER ABOUT THE INCIDENT AFTER THE WOUND DISAPPEARED. IT WAS LIKE AN "FYI"; THEREFORE, WE ARE UNABLE TO CONFIRM OR REJECT THE PATIENT'S CLAIM, AND CURRENTLY THE PATIENT IS DOING FINE.

Description of Event or Problem · 1

ON JANUARY 30, 2008 REP INFORMED RESMED THAT THE THERAPIST TOLD HIM THAT HER PATIENT TOLD HER THAT THE HUMIDIFIER OVERHEATED DURING THE NIGHT, USING UP ALL THE WATER AND CREATED A BURNING SMELL RESULTING IN A 2ND DEGREE BURN IN THE PATIENT'S LEFT NOSTRIL WHILE WEARING THE SWIFT MASK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HUMIDAIRE 3I-AMERICAS	HUMIDAIRE 3I-AMERICAS	BTT	RESMED LTD.	33906	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1