Brand Name | INSPIRATION ELITE |
Type of Device | COMPRESSOR, AIR, PORTABLE, |
Manufacturer (Section D) |
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD |
chichester business park |
city fields way, tangmere |
chichester, west sussex PO20 2FT |
UK PO20 2FT |
|
Manufacturer Contact |
alessandro
agosti
|
chichester business park |
city fields way, tangmere |
chichester, west sussex PO20 -2FT
|
UK
PO20 2FT
|
704231549
|
|
MDR Report Key | 7150964 |
MDR Text Key | 95954780 |
Report Number | 9681154-2017-00022 |
Device Sequence Number | 1 |
Product Code |
CAF
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K042655 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/07/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | 1049906 |
Device Catalogue Number | 1049906 |
Device Lot Number | 13M-0205 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/11/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/07/2017
|
Initial Date FDA Received | 12/28/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/01/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|