MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for MOTOR EXTERNAL DRIVE 560A manufactured by Perfusion Systems.
Report Number | 2184009-2020-00018 |
MDR Report Key | 9860296 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-20 |
Date of Report | 2020-03-20 |
Date of Event | 2020-02-19 |
Date Mfgr Received | 2020-02-20 |
Device Manufacturer Date | 2019-08-21 |
Date Added to Maude | 2020-03-20 |
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 | PHYSICIAN ASSISTANT |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | PAULA BIXBY |
Manufacturer Street | 8200 CORAL SEA STREET NE |
Manufacturer City | MOUNDS VIEW MN 55112 |
Manufacturer Country | US |
Manufacturer Postal | 55112 |
Manufacturer Phone | 7635055378 |
Manufacturer G1 | PERFUSION SYSTEMS |
Manufacturer Street | 7611 NORTHLAND DR |
Manufacturer City | BROOKLYN PARK MN 55428 |
Manufacturer Country | US |
Manufacturer Postal Code | 55428 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MOTOR EXTERNAL DRIVE |
Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
Product Code | DWA |
Date Received | 2020-03-20 |
Returned To Mfg | 2020-03-02 |
Model Number | 560A |
Catalog Number | 560A |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | PERFUSION SYSTEMS |
Manufacturer Address | 7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-20 |