BERLIN HEART EXCOR VAD P10P 10M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-01 for BERLIN HEART EXCOR VAD P10P 10M manufactured by Berlin Heart.

Event Text Entries

[41981235] Perfusion was priming berlin heart excor vad (p10p 10m #(b)(4)) and discovered plastic in the valve of the heart which could not be removed through priming. Therefore a second backup berlin heart was primed and used.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5061459
MDR Report Key5546856
Date Received2016-04-01
Date of Report2016-03-18
Date of Event2016-03-18
Date Added to Maude2016-04-05
Event Key0
Report Source CodeVoluntary 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 Report0

Device Details

Brand NameBERLIN HEART EXCOR VAD
Generic NameBERLIN HEART EXCOR VAD
Product CodePCK
Date Received2016-04-01
Model NumberP10P 10M
Lot Number1320554
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBERLIN HEART


Patients

Patient NumberTreatmentOutcomeDate
10 2016-04-01

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