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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 107754
Device Problems Fracture (1260); Mechanical Problem (1384); Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted once the manufacturer's investigation is completed.
 
Event Description
It was reported that the patient's mobile power unit (mpu) cracked where the v-lock connection is made. The patient was connected to the mpu when it became disconnected, received a critical alarm due to power loss, and was running on the backup battery for about 5 minutes. The power cable was no longer secured. The mpu was pulled out of service and the patient used batteries.
 
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Brand NameHEARTMATE MOBILE POWER UNIT, NA
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key13978642
MDR Text Key289889521
Report Number2916596-2022-01701
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number107754
Device Catalogue Number107754
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2020
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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