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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE VENTRICULAR (ASSISST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE VENTRICULAR (ASSISST) BYPASS Back to Search Results
Device Problems Fracture (1260); Use of Device Problem (1670); Material Twisted/Bent (2981)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 09/19/2013
Event Type  malfunction  
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key14461209
Report Number3007042319-2022-05172
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/20/2022 Patient Sequence Number: 1
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