MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-07 for OM-10000 manufactured by Maquet (suzhou) Co.,ltd..
[188401561]
Trackwise id #(b)(4). A lot history record review was completed for the reported product lot number. There were no ncmr? S for the reported lot number. 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.
Patient Sequence No: 1, Text Type: N, H10
[188401562]
The hospital reported that during a coronary artery bypass procedure using acrobat-i stabilizer, they found that the vacuum tube is being detached while connecting with vacuum port. It results improper fixation of the system on the tissue of surgical site. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2020-00018 |
| MDR Report Key | 9557264 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-15 |
| Device Manufacturer Date | 2018-06-27 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OM-10000 |
| Generic Name | STABILIZER, HEART |
| Product Code | MWS |
| Date Received | 2020-01-07 |
| Model Number | OM-10000 |
| Catalog Number | OM-10000 |
| Lot Number | 25139919 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET (SUZHOU) CO.,LTD. |
| Manufacturer Address | NO.158 FANG ZHOU ROAD SUZHOU INDUSTRIAL PARK SUZHOU US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |