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 2019-05-28 for ACROBAT-I STABILIZER OM-10000 manufactured by Maquet Cardiovascular Llc.
[146340760]
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
[146340761]
The hospital reported that during a coronary artery bypass procedure using om1000, they stated that the access rail platform standard blade connected to the drive mechanism had a piece break off into patients cavity. The piece was the black notch that holds the suture. The hospital did not report any patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2019-00613 |
| MDR Report Key | 8648398 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-05-08 |
| Date Mfgr Received | 2019-11-11 |
| Device Manufacturer Date | 2019-02-19 |
| Date Added to Maude | 2019-05-28 |
| 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 | ACROBAT-I STABILIZER |
| Generic Name | STABILIZER, HEART |
| Product Code | MWS |
| Date Received | 2019-05-28 |
| Catalog Number | OM-10000 |
| Lot Number | 25144801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Address | 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-28 |