MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE UNIVERSAL BATTERYCHARGER; UNIVERSAL BATTERY CHARGER

Catalog Number 1440

Device Problems Fire (1245); Smoking (1585); Electrical Shorting (2926)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The universal battery charger is not a single use device.Approximate age of the device is 5 months (calculated from the ship date of the universal battery charger).The device was returned for analysis.Evaluation is not complete.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.It was reported that the patient was asleep when a noise from the universal battery charger (ubc) was heard, and then sparks and smoke were observed coming from the ubc.A ¿telephone symbol¿ was observed on the ubc display.There was no liquid that had been spilled on the ubc.The ubc was taken out of service and a replacement unit issued to the patient.There was no report of an adverse effect associated with this event.

Manufacturer Narrative

The returned universal battery charger (ubc) was evaluated by the manufacturer's technical services group and the reported issue was verified.During testing of the returned ubc, the red light symbol adjacent to slot #2 illuminated and phone error code s0003 was observed.Troubleshooting of the device found two burnt/damaged components on the power supply printed circuit board (pcb).Once the pcb was replaced, a full functional checkout was performed and the unit passed all tests.The root cause of the damaged components could not be conclusively determined.Once the damaged components were replaced, the device functioned as intended.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE UNIVERSAL BATTERYCHARGER
• 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: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6577089
• MDR Text Key: 75500397
• Report Number: 2916596-2017-01041
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• 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
• Report Date: 07/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1440
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• 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: 59 YR
• Patient Weight: 103