Brand Name | DREAMSTATION |
Type of Device | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING |
Manufacturer (Section D) |
|
MDR Report Key | 15067464 |
MDR Text Key | 296347011 |
Report Number | MW5110996 |
Device Sequence Number | 1 |
Product Code |
MNS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
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? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 07/19/2022 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 43 YR |
Patient Sex | Male |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|