MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 E/P PACK; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 28-98-00

Device Problems Failure to Power Up (1476); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 e/p pack.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The livanova field service representative who was on site performing service at the time of the report installed a loaner device and performed software, functional and electrical safety checks before returning the device to service.The replaced e/p pack was returned to livanova (b)(4) for further evaluation.During the investigation, the reported issue was confirmed and the root cause was traced to a defective power supply.The power supply was replaced and the device was tested without further issues.A technical safety inspection was performed and the device was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that an unusual noise was noticed coming from from the s5 e/p pack during maintenance and that the s5 has recently had issues powering up in mains mode and would only power on in battery mode.The customer reported that the noise has not occurred previously.There was no patient involvement.

Manufacturer Narrative

The power supply was sent to the manufacturer for further investigation.It was found out that the booster voltage breaks down under applied load.As root cause a defect in the controller of the booster of the power supply was identified.

• Brand Name: S5 E/P PACK
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6854986
• MDR Text Key: 85904802
• Report Number: 9611109-2017-00700
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28-98-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1