• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1104
Device Problems Failure to Pump (1502); Pumping Stopped (1503)
Patient Problem Cardiac Arrest (1762)
Event Date 03/08/2022
Event Type  Death  
Event Description
It was reported that ventricular assist device (vad) power was connected to alternating current (ac) adapter electricity and battery power, connected at the same time, when there was a power outage and the patient accidentally took the battery out of the controller with resulting unexpected power loss to two controllers leading to a vad stop. The vad would not restart once reconnected to power. The patient went into cardiac arrest, received some medications and after unsuccessful attempts to resuscitate the patient, the patient expired.
 
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, model #: 1420 / catalog #: 1420 / expiration date: 30-june-2020 / serial#: (b)(4), udi #: (b)(4). Device available for evaluation: no. Mfg date: 03-june-2019, labeled for single use: no. (b)(4). Brand name: heartware ventricular assist system ¿ controller, model #: 1420 / catalog #: 1420 / expiration date: 30-june-2020 / serial#: (b)(4), udi #: (b)(4). Device available for evaluation: no. Mfg date: 03-june-2019, labeled for single: no. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13722343
MDR Text Key286944313
Report Number3007042319-2022-02926
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeSF
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,Followup
Report Date 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2022
Is this an Adverse Event Report? Yes
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
Date Manufacturer Received06/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2018
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: 03/10/2022 Patient Sequence Number: 1
-
-