Brand Name | OXY-1 CONSOLE |
Type of Device | ABIOMED BREETHE OXY-1 SYSTEM |
Manufacturer (Section D) |
ABIOMED INC. |
22 cherry hill drive |
danvers MA 01923 |
|
Manufacturer (Section G) |
BREETHE INC. |
1500 joh ave suite 190 |
|
halethorpe MD 21227 |
|
Manufacturer Contact |
ralph
barisano
|
22 cherry hill drive |
danvers, MA 01923
|
9786461400
|
|
MDR Report Key | 13042507 |
MDR Text Key | 283693700 |
Report Number | 1220648-2021-01205 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
UDI-Device Identifier | 860001797930 |
UDI-Public | (01)860001797930(10)20200309(11)201027 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K200109 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
06/02/2022 |
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 |
Health Professional
|
Device Model Number | OXY-1 CONSOLE |
Device Catalogue Number | 001-3300-011 |
Device Lot Number | 20200309 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/20/2021 |
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 08/17/2021 |
Initial Date Manufacturer Received |
08/17/2021 |
Initial Date FDA Received | 12/20/2021 |
Supplement Dates Manufacturer Received | 08/17/2021
|
Supplement Dates FDA Received | 06/02/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/27/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 55 YR |
Patient Sex | Male |
Patient Ethnicity | Non Hispanic |
Patient Race | White |