N
Patient 1
TRACKWISE ID #(B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
MAUDE MDR 9845654
- MDR report key
- 9845654
- Report number
- 2242352-2020-00256
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 45 BARBOUR POND DRIVE WAYNE NJ 07470 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OM-10000 | STABILIZER, HEART | MAQUET CARDIOVASCULAR LLC | MWS | OM-10000 | OM-10000 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-17 | 0 |
Event Narratives#
D
Patient 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER GROUND PIN HAS BROKEN. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.