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 | 9934025 |
MDR Text Key | 186783077 |
Report Number | 2518422-2020-00847 |
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 |
|
Type of Report
| Initial,Followup |
Report Date |
05/26/2020 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 04/08/2020 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
LAY USER/PATIENT
|
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 05/26/2020 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unkown
|
Patient TREATMENT DATA |
Date Received: 04/08/2020 Patient Sequence Number: 1 |
|
|