Brand Name | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) |
Type of Device | 868.5440 |
Manufacturer (Section D) |
RESPIRONICS INC |
1010 murry ridge lane |
murrysville PA 15668 |
|
MDR Report Key | 3948740 |
MDR Text Key | 4602869 |
Report Number | 1531186-2014-02686 |
Device Sequence Number | 1 |
Product Code |
CAW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Invalid Data |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
07/22/2014,06/16/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/22/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | IRC1710 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/22/2014 |
Distributor Facility Aware Date | 06/16/2014 |
Device Age | 3 YR |
Date Report to Manufacturer | 07/22/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|