Brand Name | DREAMSTATION AUTO CPAP |
Type of Device | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
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, PA 15206
|
2673970028
|
|
MDR Report Key | 15076960 |
MDR Text Key | 300653165 |
Report Number | 2518422-2022-61670 |
Device Sequence Number | 1 |
Product Code |
BZD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K131982 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
04/18/2023 |
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
|
Device Model Number | DSX500H11C |
Device Catalogue Number | DSX500H11C |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/08/2022
|
Initial Date FDA Received | 07/21/2022 |
Supplement Dates Manufacturer Received | 03/17/2023
|
Supplement Dates FDA Received | 04/18/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/14/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | RES 88058 |
Patient Sequence Number | 1 |
Patient Sex | Female |
|
|