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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 Problem Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/03/2022
Event Type  malfunction  
Event Description
It was reported that on the morning of (b)(6) 2022, the patient noted that while on the mobile power unit (mpu), the plug came unplugged from the wall.The event log recorded no external power events on (b)(6) 2022 which were caused by the power to the mpu being briefly interrupted.The emergency backup battery was used to support the system during these events.The cause of the low voltage and replace backup battery alarms was the cord being pulled from the wall while the patient was on mpu and the mpu placement was adjusted to prevent the cord from coming out of the wall.The mpu has a v-lock connector and that it did not come loose from the wall or the back of the unit.The mpu was not removed from service.
 
Manufacturer Narrative
Patient's gender was requested but was not provided due to hospital policy.Manufacturer's investigation conclusion: the reported event of no external power alarms was able to be confirmed.The mobile power unit (mpu) (serial number: (b)(4)) was not returned for analysis; however, a log file was submitted for review.A review of the submitted log files showed events spanning approximately 14 days ((b)(6) 2022 per timestamp).No external power alarms coincident with a loss of ac power were active on (b)(6) 2022 from 13:49:33 ¿ 13:49:39, on (b)(6) 2022 from 12:25:17 ¿ 12:25:22, and on (b)(6) 2022 from 08:23:38 ¿ 08:23:41 while the controller was connected to the mpu.The backup battery was able to provide power to the system during the alarms.The alarms cleared once power was restored.There were no other notable alarms active in the log file.Pump operation was not affected.The root cause of the reported event of no external power alarms on (b)(6) 2022 were reported to have been caused by the ac power cord coming loose from the outlet.The root cause of the other reported no external power alarms was unable to be conclusively determined through this investigation.The device history records were reviewed for the mpu (serial number: (b)(4)) and was found to pass all manufacturing and qa specifications before being shipped to the customer on (b)(6) 2021.Heartmate iii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook (doc.#10006136, rev.D) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including no external power alarms.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
HEARTMATE MOBILE POWER UNIT, NA
Type of Device
VENTRICULAR (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 Key15128756
MDR Text Key298710791
Report Number2916596-2022-12496
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024010883
UDI-Public813024010883
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 Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number107754
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/14/2022
Initial Date FDA Received07/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age56 YR
Patient Weight61 KG
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