MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-08 for OM-10000 manufactured by Maquet (suzhou) Co.,ltd..
[188404307]
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
[188404308]
The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer suction connector broke off upon connecting. 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 | 2242352-2020-00033 |
| MDR Report Key | 9566221 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-08 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-16 |
| Date Added to Maude | 2020-01-08 |
| 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 | 2020-01-08 |
| Returned To Mfg | 2020-01-09 |
| Model Number | OM-10000 |
| Catalog Number | OM-10000 |
| Lot Number | 25147609 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-08 |