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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 2060
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
Event Type  malfunction  
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK
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 Key14633421
Report Number3007042319-2022-05357
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2060
Device Catalogue Number2060
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/06/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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