MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-19 for XPER FLEX CARDIO PHYSIOMONITORING SYSTEM 453564243601 manufactured by Invivo Corporation.
Report Number | 1051786-2020-00014 |
MDR Report Key | 9856239 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2020-03-19 |
Date of Report | 2020-03-12 |
Date Mfgr Received | 2020-03-12 |
Device Manufacturer Date | 2016-04-21 |
Date Added to Maude | 2020-03-19 |
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 |
Reporter Occupation | BIOMEDICAL ENGINEER |
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 | XPER FLEX CARDIO PHYSIOMONITORING SYSTEM |
Generic Name | CARDIOVASCULAR MONITOR |
Product Code | MWI |
Date Received | 2020-03-19 |
Model Number | 453564243601 |
Catalog Number | 453564243601 |
Lot Number | N/A |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | N |
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 | 2020-03-19 |