Brand Name | INNOSPIRE ELEGANCE NEBULIZER |
Type of Device | COMPRESSOR, AIR, PORTABLE |
Manufacturer (Section D) |
RESPIRONICS, INC. |
murrysville PA |
|
Manufacturer Contact |
alessandro
agosti, manager
|
city fields way, tangmere |
chichester business park |
chichester, west sussex PO20 -2FT
|
UK
PO20 2FT
|
8704231549
|
|
MDR Report Key | 3591183 |
MDR Text Key | 16554031 |
Report Number | 9681154-2014-00001 |
Device Sequence Number | 1 |
Product Code |
BTI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K042655 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
11/25/2013 |
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 | 1099969 |
Device Catalogue Number | 1099969 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/25/2013 |
Initial Date FDA Received | 01/15/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|