IMPELLA 0048-0003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-24 for IMPELLA 0048-0003 manufactured by Abiomed, Inc..

Event Text Entries

[92875355]
Patient Sequence No: 1, Text Type: N, H10


[92875356] Device stopped due to fail safe perimeters.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7057417
MDR Report Key7057417
Date Received2017-11-24
Date of Report2017-10-10
Date of Event2017-10-03
Report Date2017-10-10
Date Reported to FDA2017-10-10
Date Reported to Mfgr2017-10-10
Date Added to Maude2017-11-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPELLA
Generic NameTEMPORARY CARDIAC SUPPORT BLOOD PUMP
Product CodePBL
Date Received2017-11-24
Catalog Number0048-0003
ID Number453054401-00480003
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerABIOMED, INC.
Manufacturer Address22 CHERRY HILL DR. DANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-24

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