Brand Name | BIPAP A30 |
Type of Device | CONTINUOUS VENTILATOR, NON-LIFE SUPPORTING |
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 |
kimberly
shelly
|
6501 living place |
pittsburgh, PA 15208
|
4125423300
|
|
MDR Report Key | 18219390 |
MDR Text Key | 329149223 |
Report Number | 2518422-2023-32028 |
Device Sequence Number | 1 |
Product Code |
MNS
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K113053 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
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 |
Health Professional
|
Device Model Number | CN1111143 |
Device Catalogue Number | CN1111143 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/30/2023
|
Initial Date FDA Received | 11/28/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|