Brand Name | REMSTAR AUTO A-FLEX |
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 15206
|
2673970028
|
|
MDR Report Key | 15164637 |
MDR Text Key | 297245277 |
Report Number | 2518422-2022-69073 |
Device Sequence Number | 1 |
Product Code |
BZD
|
UDI-Device Identifier | 00606959030725 |
UDI-Public | 00606959030725 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K131982 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
08/04/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/04/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | FR565S |
Device Catalogue Number | FR565S |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/15/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/11/2013 |
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 |
|
|