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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1420
Device Problems Battery Problem (2885); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2021
Event Type  malfunction  
Manufacturer Narrative
Additional products: heartware ventricular assist system ¿battery model #: 1650/ catalog #: 1650/ expiration date: 30-jun-2021 / serial or lot#: bat901014 udi #: (b)(4) device evaluated: no, device evaluation anticipated, but not yet begun mfg date: 18-jun-2020 labeled for single use: no patient ime code(s): (b)(4) imf code(s): (b)(4) img code(s): (b)(4) fda device code(s): (b)(4) investigation of this event is pending and a supplemental report will be sent upon its completion. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that while connected to the controller, the battery twice drained to below 25% with critical battery alarms and the controller failed to switch to the fully charged battery on the other side. The battery was replaced and the controller remains in use. No patient complications have been reported as a result of this event.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
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 Key11930636
MDR Text Key254241982
Report Number3007042319-2021-03821
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model Number1420
Device Catalogue Number1420
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 Received07/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2020
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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