Brand Name | EVERFLO OXYGEN CONCENTRATOR |
Type of Device | GENERATOR, OXYGEN, PORTABLE |
Manufacturer (Section D) |
PHILIPS RESPIRONICS INC. |
1001 murry ridge lane |
murrysville, pa |
|
Manufacturer (Section G) |
PHILIPS RESPIRONICS INC. |
1001 murry ridge lane |
|
murrysville, pa |
|
Manufacturer Contact |
adam
price
|
1001 murry ridge lane |
murrysville, pa
|
|
MDR Report Key | 10482736 |
MDR Text Key | 205309497 |
Report Number | 2518422-2020-02013 |
Device Sequence Number | 1 |
Product Code |
CAW
|
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 |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/13/2020 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | 1020000 |
Device Catalogue Number | 1020000 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/13/2020 |
Initial Date FDA Received | 09/02/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/03/2014 |
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) |
Required Intervention;
|
Patient Age | 61 YR |