Brand Name | CYLINDER,ULTRAFILL,MB08,3000 PSI |
Type of Device | GENERATOR, OXYGEN, PORTABLE |
Manufacturer (Section D) |
RESPIRONICS, INC. |
175 chastian meadows court |
kennesaw GA 30144 3724 |
|
MDR Report Key | 7270684 |
MDR Text Key | 100135845 |
Report Number | 1040777-2018-00004 |
Device Sequence Number | 1 |
Product Code |
CAW
|
UDI-Device Identifier | 00606959032477 |
UDI-Public | 00606959032477 |
Combination Product (y/n) | N |
PMA/PMN Number | K091191 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Type of Report
| Initial,Followup |
Report Date |
01/24/2018 |
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 |
Lay User/Patient
|
Device Model Number | 1065715 |
Device Catalogue Number | 1065715 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/05/2018 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/24/2018 |
Initial Date FDA Received | 02/14/2018 |
Supplement Dates Manufacturer Received | 01/15/2019
|
Supplement Dates FDA Received | 01/18/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ULTRAFILL DEVICE, SERIAL NUMBER (B)(4) |
|
|