Brand Name | 1 SYSTEM ONE |
Type of Device | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING |
Manufacturer (Section D) |
PHILIPS / RESPIRONICS, INC. |
|
|
MDR Report Key | 13061785 |
MDR Text Key | 282726436 |
Report Number | MW5106228 |
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 |
12/19/2021 |
3 Devices were Involved in the Event: |
1
2
3
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/21/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 650P |
Was Device Available for Evaluation? |
Yes
|
Patient Sequence Number | 1 |
Treatment | CETIRIZINE; DOXAZOSIN; DOXYCYCLINE; DREAMSTATION BI-PAP; FLOMAX; HUMALOG INSULIN; LANTUS ; LEVOTHYROXINE; LISINOPRIL; MULTI VITAMIN ; PHENYTOIN SODIUM; ROPINIROLE; SERTRALINE; SIMVASTATIN; TYLENOL |
Patient Outcome(s) |
Other;
Life Threatening;
Disability;
Required Intervention;
|
Patient Age | 63 YR |
Patient Sex | Male |
Patient Weight | 79 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|