Brand Name | BIPAP AVAPS CSERIES |
Type of Device | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING |
Manufacturer (Section D) |
PHILIPS RESPIRONICS INC. |
1001 murry ridge lane |
murrysville PA 15668 |
|
Manufacturer (Section G) |
PHILIPS RESPIRONICS INC. |
1001 murry ridge lane |
|
murrysville PA 15668 |
|
Manufacturer Contact |
adam
price
|
1001 murry ridge lane |
murrysville, PA 15668
|
|
MDR Report Key | 12009571 |
MDR Text Key | 256506619 |
Report Number | 2518422-2021-01718 |
Device Sequence Number | 1 |
Product Code |
MNS
|
UDI-Device Identifier | 00606959015777 |
UDI-Public | 00606959015777 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K102465 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
06/16/2021 |
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
|
Device Model Number | CN1167HS |
Device Catalogue Number | CN1167HS |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/11/2021
|
Initial Date FDA Received | 06/16/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/05/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|