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Adverse Event Report

DEVILBISS HEALTH CARE DEVILBISS MC 44 OXYGEN CONCENTRATOR   back to search results
Model Number MC44
Event Type  Death   Patient Outcome  Death;
Event Description

An oxygen concentrator was involved in a fatality. Pt was smoking a cigarette while attached to her oxygen concentrator. Pt was found burned.

 
Manufacturer Narrative

Device labeling warns against smoking while the oxygen concentrator is in use.

 
Search Alerts/Recalls

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Brand NameDEVILBISS MC 44
Type of DeviceOXYGEN CONCENTRATOR
Baseline Brand NameMC44
Baseline Generic NameOXYGEN CONCENTRATOR
Baseline Catalogue NumberMC44
Baseline Model NumberMC44
Baseline Device FamilyOXYGEN CONCENTRATOR
Baseline Device 510(K) NumberK872470
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed08/03/1987
Manufacturer (Section F)
DEVILBISS HEALTH CARE
1200 east main st
somerset PA 15501
Manufacturer (Section D)
DEVILBISS HEALTH CARE
1200 east main st
somerset PA 15501
Manufacturer (Section G)
SUNRISE MEDICAL
100 devilbiss dr.
somerset PA 15501
Manufacturer Contact
carolyn troast
1200 e. main st.
somerset , PA 15501
(814) 443 -7690
Device Event Key66033
MDR Report Key65946
Event Key61992
Report Number2515872-1997-00001
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/15/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL NumberMC44
Device Catalogue NumberMC44
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Invalid Data
Date Manufacturer Received12/19/1996
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1992
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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