Brand Name | BIPAP VISION |
Type of Device | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE |
Manufacturer (Section D) |
RESPIRONICS, INC. |
1001 murry ridge lane |
murrysville PA 15668 |
|
Manufacturer (Section G) |
RESPIRONICS, INC. |
1001 murry ridge lane |
|
murrysville PA 15668 |
|
Manufacturer Contact |
wilfredo
alvarez
|
312 alvin drive |
new kensington, PA 15068
|
7243349303
|
|
MDR Report Key | 5184779 |
MDR Text Key | 29742143 |
Report Number | 2518422-2015-03501 |
Device Sequence Number | 1 |
Product Code |
MNT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K982454 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
10/06/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/28/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 582059 |
Device Catalogue Number | 582059 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/06/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/09/2008 |
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) |
Required Intervention;
|
Patient Age | 50 YR |
|
|