MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE UNIVERSAL BATTERY CHARGER

Catalog Number 1440

Device Problems Smoking (1585); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The universal battery charger is not a single use device.Approximate age of the device is 80 days (calculated from the ship date of the universal battery charger).The device is expected to be returned for evaluation.It has not yet been received no further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016.On (b)(6) 2016, it was reported that the patient's spouse plugged in the battery charger at approximately 12:30 am and a loud popping sound was heard.At the same time, the battery charger began to emit smoke from under the handle and the patient's spouse unplugged the device.Upon contacting their healthcare professionals, the patient was advised against plugging in the battery charger.At the time of the event, the patient had 6 fully charged batteries and a power module for immediate use as a backup power source.There was no report of any adverse impact during the event.No additional information was provided.

Manufacturer Narrative

The report that the heartmate universal battery charger (ubc) made a loud popping noise and it started to emit smoke when plugged into the ac line power was inconclusive and could not be determined as the ubc was not returned for evaluation.No further information was provided.The manufacturer is closing its file on this event.

Manufacturer Narrative

The battery charger was returned for evaluation.The evaluation of the returned battery charger revealed fluid residue on the power supply printed circuit board (pcb).Additionally, corrosion was noted on slot #2.Findings indicate that the reported issue was a result of fluid ingress; however, the root cause of the fluid ingress could not be conclusively determined.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE UNIVERSAL BATTERY CHARGER
• Type of Device: UNIVERSAL BATTERY CHARGER
• 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 ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 5553089
• MDR Text Key: 42036092
• Report Number: 2916596-2016-00650
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1440
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 112