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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1104
Device Problems Failure to Pump (1502); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional products: brand name: heartware ventricular assist system ¿ controller 2. 0, model #: 1420-controller/ catalog #:1420-controller / expiration date: 29-feb-2020 / serial #: (b)(4), udi #: (b)(4), device available for evaluation: no, device mfg date: 07-feb-2019, labeled for single use: no. Additional information has been requested for type of pump failure and if there is controller fault alarms of the event, but it was not available at the time of this report. If additional information is received, the event will be updated and a supplemental report will be sent. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the controller had a depleting internal battery and the ventricular assist device (vad) was failing to restart. The controller was exchanged and the vad remains in use. No patient complications have been reported as a result of this event.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
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 Key11348130
MDR Text Key232560125
Report Number3007042319-2021-01650
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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