FDA Adverse Event Other Summary report: N

UNKNOWN BRAND OF SALTER LABS CANNULA

MDR report key: 2651975 · Received July 5, 2012

Report

Report Number
2921601-2012-00007
Event Type
Other
Date Received
July 5, 2012
Date of Event
June 25, 2012
Report Date
July 5, 2012
Manufacturer
SALTER LABS
Product Code
CAT
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

ON (B)(6) 2012, SALTER LABS RECEIVED A CALL FROM A FIRE INVESTIGATOR, REGARDING A FIRE THAT INVOLVED AN UNKNOWN BRAND OF SALTER LABS CANNULA. THE FIRE INVESTIGATOR REQUESTED A COPY OF THE MSDS FOR THE MATERIAL FROM WHICH THE CANNULA IS MADE. SALTER LABS PROVIDED THIS INFORMATION. THE PATIENT REPORTEDLY EXPERIENCED BURNS TO HIS LEGS WHEN A FIRE TRAVELED DOWN THE CANNULA FROM THE CONCENTRATOR (NOT MANUFACTURED BY SALTER LABS). THE PATIENT REPORTS THAT HE WAS IN THE KITCHEN AT THE TIME THE FIRE BROKE OUT AND THE CONCENTRATOR WAS IN THE LIVING ROOM (ABOUT 40 FEET AWAY). ACCORDING TO THE FIRE INVESTIGATOR, THE PATIENT (A SMOKER) DENIED SMOKING AT OR AROUND THE TIME OF THE INCIDENT. THE PATIENT WAS UNABLE TO LOCATE THE CANNULA INVOLVED IN THE INCIDENT AND IT IS UNAVAILABLE FOR ANALYSIS BY SALTER LABS. THE BRAND OR LOT OF THE CANNULA INVOLVED IS NOT KNOWN. WITHOUT THE CANNULA AND THE CONCENTRATOR INVOLVED IN THE INCIDENT, IT IS NOT POSSIBLE TO DETERMINE A LIKELY ROOT CAUSE OF THE FIRE. THE PATIENT REPORTEDLY IS RECOVERING "FINE." THIS IS A FINAL REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNKNOWN BRAND OF SALTER LABS CANNULA NASAL CANNULA CAT SALTER LABS UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 UNK Other