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 2019-11-25 for OM-10000 manufactured by Maquet (suzhou) Co.,ltd..
[183872824]
Trackwise (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 been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[183872825]
The hospital reported that during a coronary artery bypass procedure using acrobat-i stabilizer. A thread is put on the suture holder of the access rail platform, and when the thread is taken out, the holder fixing part pops out. 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 | 2242352-2019-01297 |
| MDR Report Key | 9368807 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-11-03 |
| Date Mfgr Received | 2019-11-05 |
| Device Manufacturer Date | 2019-05-14 |
| Date Added to Maude | 2019-11-25 |
| 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 | NO.158 FANG ZHOU ROAD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU |
| Manufacturer Country | US |
| Manufacturer G1 | MAQUET (SUZHOU) CO.,LTD. |
| Manufacturer Street | NO.158 FANG ZHOU ROAD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU |
| Manufacturer Country | US |
| 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 | 2019-11-25 |
| Returned To Mfg | 2019-11-18 |
| Model Number | OM-10000 |
| Catalog Number | OM-10000 |
| Lot Number | 25146526 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-11-25 |