Brand Name | EVERFLO OXYGEN CONCENTRATOR |
Type of Device | GENERATOR, OXYGEN, PORTABLE |
Manufacturer (Section D) |
RESPIRONICS, INC. |
175 chastian meadows court |
kennesaw GA 30144 3724 |
|
Manufacturer (Section G) |
RESPIRONICS, INC. |
175 chastian meadows court |
|
kennesaw GA 30144 3724 |
|
Manufacturer Contact |
adam
price
|
312 alvin drive |
new kensington, PA 15068
|
7243349303
|
|
MDR Report Key | 7270683 |
MDR Text Key | 100071625 |
Report Number | 1040777-2018-00005 |
Device Sequence Number | 1 |
Product Code |
CAW
|
UDI-Device Identifier | 00606959022041 |
UDI-Public | 00606959022041 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K061261 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
02/08/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 1020001 |
Device Catalogue Number | 1020001 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/20/2018 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/08/2018 |
Initial Date FDA Received | 02/14/2018 |
Supplement Dates Manufacturer Received | 03/28/2018
|
Supplement Dates FDA Received | 03/30/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/07/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|