MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-08 for ACROBAT-I POSITIONER XP-5000 manufactured by Maquet Cardiovascular Llc.
[188570022]
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. Since the device is not available to be returned to us, a technical evaluation cannot be performed. Per our standard sop's, all events are tracked and trended to determine whether or not any trends develope. Device was discarded.
Patient Sequence No: 1, Text Type: N, H10
[188570023]
The hospital reported that during a coronary artery bypass procedure using acrobat-i positioner. They fixed the fixed position and turned the knob, but i couldn't fix it by spinning around. (mechanical issue) 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 | 2242352-2020-00025 |
| MDR Report Key | 9565892 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2019-12-19 |
| Device Manufacturer Date | 2019-06-17 |
| 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 | 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 POSITIONER |
| Generic Name | STABILIZER, HEART |
| Product Code | MWS |
| Date Received | 2020-01-08 |
| Model Number | XP-5000 |
| Catalog Number | XP-5000 |
| Lot Number | 25146961 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-08 |