PULSION PULSIOCATH THERMODILUTION CATHETERS PV2015L20-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-17 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2015L20-A manufactured by Pulsion Medical Systems Se.

MAUDE Entry Details

• Report Number: 3003263092-2020-00001
• MDR Report Key: 9716692
• Report Source: COMPANY REPRESENTATIVE,DISTRI
• Date Received: 2020-02-17
• Date of Report: 2020-03-13
• Date of Event: 2019-10-06
• Date Mfgr Received: 2020-03-11
• Device Manufacturer Date: 2018-10-01
• Date Added to Maude: 2020-02-17
• 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: MS. CHRISTINA CARLSOHN
• Manufacturer Street: HANS-RIEDL-STRASSE 17
• Manufacturer City: FELDKIRCHEN 85622
• Manufacturer Country: GM
• Manufacturer Postal: 85622
• Manufacturer Phone: 0894599140
• Manufacturer G1: PULSION MEDICAL SYSTEMS SE
• Manufacturer Street: HANS-RIEDL-STRASSE 17
• Manufacturer City: FELDKIRCHEN 85622
• Manufacturer Country: GM
• Manufacturer Postal Code: 85622
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PULSION PULSIOCATH THERMODILUTION CATHETERS
• Generic Name: PROBE, THERMODILUTION
• Product Code: KRB
• Date Received: 2020-02-17
• Model Number: PV2015L20-A
• Catalog Number: PV2015L20-A
• Lot Number: 660718
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PULSION MEDICAL SYSTEMS SE
• Manufacturer Address: HANS-RIEDL-STRASSE 17 FELDKIRCHEN 85622 GM 85622

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-17