MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for MODUTEC ARD517001948 manufactured by Maquet Sas.
[136116842]
The issue is still being investigated by manufacturing site. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136116843]
On (b)(4) 2019 maquet (b)(4) became aware of an issue with one of devices- modutec. As it was stated, device was damaged from repeated collisions and parts fell off. There was no injury reported however we decided to report the issue in abundance of caution as the parts falling off may lead to an adverse event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2019-00034 |
| MDR Report Key | 8321423 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-06-05 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-16 |
| Date Added to Maude | 2019-02-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PARC DE LIM AVENUE DE LA POMME DE PI |
| Manufacturer City | ORL 45074 |
| Manufacturer Country | FR |
| Manufacturer Postal | 45074 |
| Manufacturer Phone | 0332382587 |
| Manufacturer G1 | PASCAL JAY - MAQUET SAS |
| Manufacturer Street | PARC DE LIM AVENUE DE LA POMME DE PI |
| Manufacturer City | ORL 45074 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 45074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MODUTEC |
| Generic Name | TUBING, PRESSURE AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2019-02-08 |
| Catalog Number | ARD517001948 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | ORL?ANS CEDEX 2 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-08 |