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, PO20 2FT |
UK PO20 2FT |
|
Manufacturer Contact |
steve
colbey
|
chichester business park |
city fields way, tangmere |
chichester, PO20 -2FT
|
UK
PO20 2FT
|
|
MDR Report Key | 7702222 |
MDR Text Key | 114417152 |
Report Number | 9681154-2018-00013 |
Device Sequence Number | 1 |
Product Code |
CAF
|
UDI-Device Identifier | 00383730001807 |
UDI-Public | 00383730001807 |
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 |
06/22/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/19/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | 1095060 |
Device Lot Number | 130918 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/10/2018 |
Date Manufacturer Received | 06/22/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/18/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|