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.
[187937090]
A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[187937091]
The customer reported alarm issue on all bed sides. The device was in use on a patient. There was no report of patient or user harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051786-2020-00013 |
| MDR Report Key | 9856129 |
| 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 |