MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-24 for PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM FC2010 453564634201 manufactured by Invivo Corporation.
[187939310]
A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[187939311]
The customer reported that the nibp (non-invasive blood pressure) would take the first set of vitals then each 5 min. Vital after would appear to pump up but would give the same values. 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 | 1051786-2020-00006 |
MDR Report Key | 9744110 |
Report Source | USER FACILITY |
Date Received | 2020-02-24 |
Date of Report | 2020-02-12 |
Date Mfgr Received | 2020-02-12 |
Device Manufacturer Date | 2017-06-20 |
Date Added to Maude | 2020-02-24 |
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 | 2020-02-24 |
Model Number | FC2010 |
Catalog Number | 453564634201 |
Lot Number | N/A |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
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 | 2020-02-24 |