Brand Name | DREAM STATION AUTO BIPAP |
Type of Device | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING |
Manufacturer (Section D) |
PHILIPS RESPIRONICS, INC. |
|
|
MDR Report Key | 15067399 |
MDR Text Key | 296338187 |
Report Number | MW5110993 |
Device Sequence Number | 1 |
Product Code |
MNS
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
07/17/2022 |
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
|
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 07/19/2022 |
Patient Sequence Number | 1 |
Patient Sex | Female |
Patient Race | Black Or African American |
|
|