|
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
|
|
|
Brand Name | DEVILBISS MC 44 |
Type of Device | OXYGEN CONCENTRATOR |
Baseline Brand Name | MC44 |
Baseline Generic Name | OXYGEN CONCENTRATOR |
Baseline Catalogue Number | MC44 |
Baseline Model Number | MC44 |
Baseline Device Family | OXYGEN CONCENTRATOR |
Baseline Device 510(K) Number | K872470 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | NA |
Date First Marketed | 08/03/1987 |
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 Key | 66033 |
MDR Report Key | 65946 |
Event Key | 61992 |
Report Number | 2515872-1997-00001 |
Device Sequence Number | 1 |
Product Code | CAW |
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 Received | 01/29/1997 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device MODEL Number | MC44 |
Device Catalogue Number | MC44 |
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 Received | 12/19/1996 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/1992 |
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
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH