MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-13 for XPER FLEX CARDIO PHYSIOMONITORING SYSTEM 453564243591 manufactured by Invivo Corporation.
[187935460]
The customer reported that the ecg waveform is automatically increasing. Additional information received indicated that, the reported issue is related to the device's sweep speed functionality. The device was in clinical use at the time the reported issue was discovered. There was no reported patient impact / injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051786-2020-00008 |
| MDR Report Key | 9829422 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2016-08-09 |
| Date Added to Maude | 2020-03-13 |
| 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 | XPER FLEX CARDIO PHYSIOMONITORING SYSTEM |
| Generic Name | PHYSIOMONITORING SYSTEM MANAGEMENT DEVICE |
| Product Code | MWI |
| Date Received | 2020-03-13 |
| Model Number | 453564243591 |
| Catalog Number | 453564243591 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-13 |