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 2020-02-19 for VOLISTA STANDOP ARDVST229037A ARD568811960/ARD568812960 manufactured by Maquet Sas.
[181997656]
Additional information will be provided upon results of investigation. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[181997657]
On (b)(6) getinge became aware of an issue with the volista device. As stated by the customer cracks on underside glass of the devices appeared. Based on provided photographic evidence we concluded that due to the breakage occurrence, some part could have fallen off the device. There was no injury reported however we decided to report the issue in abundance of caution as any parts falling into the sterile field might be a source of contamination. Manufacturer's reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2020-00019 |
| MDR Report Key | 9724822 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-02-19 |
| 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 Contact | MR. PASCAL JAY |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Manufacturer G1 | MAQUET SAS |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOLISTA STANDOP |
| Generic Name | LIGHT, SURGICAL, CEILING MOUNTED |
| Product Code | FSY |
| Date Received | 2020-02-19 |
| Model Number | ARDVST229037A |
| Catalog Number | ARD568811960/ARD568812960 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | PARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |