MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,user facilit report with the FDA on 2019-08-09 for PICCO CATHETER PV2015L20-A manufactured by Pulsion Medical Systems Se.
| Report Number | 3003263092-2019-00014 |
| MDR Report Key | 8878599 |
| Report Source | CONSUMER,FOREIGN,USER FACILIT |
| Date Received | 2019-08-09 |
| Date of Report | 2019-09-20 |
| Date of Event | 2019-07-24 |
| Date Mfgr Received | 2019-09-19 |
| Date Added to Maude | 2019-08-09 |
| 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 Street | HANS-RIEDL-STRASSE 17 |
| Manufacturer City | FELDKIRCHEN |
| Manufacturer Country | US |
| Manufacturer G1 | PULSION MEDICAL SYSTEMS SE |
| Manufacturer Street | HANS-RIEDL-STRASSE 17 |
| Manufacturer City | FELDKIRCHEN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PICCO CATHETER |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2019-08-09 |
| Catalog Number | PV2015L20-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PULSION MEDICAL SYSTEMS SE |
| Manufacturer Address | HANS-RIEDL-STRASSE 17 FELDKIRCHEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-09 |