MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM FC2010 453564634201 manufactured by Invivo Corporation.
| Report Number | 1051786-2019-00038 |
| MDR Report Key | 9145476 |
| Date Received | 2019-10-02 |
| Date of Report | 2019-09-24 |
| Date Mfgr Received | 2019-09-24 |
| Device Manufacturer Date | 2018-05-09 |
| Date Added to Maude | 2019-10-02 |
| 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. ROBERT CORNING |
| Manufacturer Street | 12151 RESEARCH PARKWAY SUITE 200 |
| Manufacturer City | ORLANDO FL 32826 |
| Manufacturer Country | US |
| Manufacturer Postal | 32826 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM |
| Generic Name | PHYSIOMONITORYING SYSTEM, INFO |
| Product Code | MWI |
| Date Received | 2019-10-02 |
| Model Number | FC2010 |
| Catalog Number | 453564634201 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORPORATION |
| Manufacturer Address | 12151 RESEARCH PARKWAY SUITE 200 ORLANDO FL 32826 US 32826 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-02 |