Brand Name | SYSTEMONE CONTINUOUS POSITIVE AIRWAY PRESSURE C-FLEX |
Type of Device | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
Manufacturer (Section D) |
PHILIPS / RESPIRONIC, INC. |
|
|
MDR Report Key | 18589731 |
MDR Text Key | 333957642 |
Report Number | MW5150785 |
Device Sequence Number | 1 |
Product Code |
BZD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
01/24/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/25/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Other;
Hospitalization;
Disability;
Life Threatening;
|
Patient Age | 52 YR |
Patient Sex | Male |
|
|