MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-07-30 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2014L16N manufactured by Pulsion Medical Systems Se.
| Report Number | 3003263092-2019-00013 |
| MDR Report Key | 8840459 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2019-07-30 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-05-14 |
| Date Mfgr Received | 2019-07-11 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2019-07-30 |
| 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 | PULSION PULSIOCATH THERMODILUTION CATHETERS |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2019-07-30 |
| Returned To Mfg | 2019-07-30 |
| Catalog Number | PV2014L16N |
| Lot Number | 619488 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-07-30 |