Brand Name | I-NEB PH UNIT |
Type of Device | NEBULIZER |
Manufacturer (Section D) |
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. |
chichester business park |
city fields way, tangmere |
chichester, PO20 2FT |
UK PO20 2FT |
|
Manufacturer (Section G) |
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. |
chichester business park |
city fields way, tangmere |
chichester, PO20 2FT |
UK
PO20 2FT
|
|
Manufacturer Contact |
rod
mel
|
chichester business park |
city fields way, tangmere |
chichester, PO20 -2FT
|
UK
PO20 2FT
|
|
MDR Report Key | 12661181 |
MDR Text Key | 277277210 |
Report Number | 9681154-2021-00017 |
Device Sequence Number | 1 |
Product Code |
CAF
|
Combination Product (y/n) | N |
PMA/PMN Number | K102454 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign |
Type of Report
| Initial |
Report Date |
10/19/2021 |
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 | R1080086 |
Device Catalogue Number | R1080086 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/05/2021 |
Initial Date FDA Received | 10/19/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/08/2021 |
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 |
Patient Outcome(s) |
Hospitalization;
|
|
|