Brand Name | BIPAP A40 |
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 | 4953334 |
MDR Text Key | 6634023 |
Report Number | 2518422-2015-02254 |
Device Sequence Number | 1 |
Product Code |
MNT
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K121623 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,foreign,health profe |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
07/13/2015 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1111170 |
Device Catalogue Number | 1111170 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/13/2015 |
Initial Date FDA Received | 07/30/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/14/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/18/2015 |
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 Age | 4 YR |
|
|