Brand Name | INNOSPIRE ESSENCE |
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 | 6696372 |
MDR Text Key | 79363160 |
Report Number | 9681154-2017-00010 |
Device Sequence Number | 1 |
Product Code |
CAF
|
UDI-Device Identifier | 00383730001814 |
UDI-Public | 00383730001814 |
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 |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/22/2017 |
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 |
No Information
|
Device Model Number | 1095060 |
Device Catalogue Number | 1099966 |
Device Lot Number | 131119 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/13/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/22/2017
|
Initial Date FDA Received | 07/10/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/19/2013 |
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 |
|
|