MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 80514-000062

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

There was no patient involved.Red status indicator flashing and warning prompt heard.

Manufacturer Narrative

The device history records for the sam 360p device and pad-pak were reviewed and this confirmed that all manufacturing and quality checks and test had been successfully completed.No rework was conducted.The sam 360p passed ¿out qat from heartsine technologies on the 2nd may 2018.On visual inspection, the membrane tail was found to have been incorrectly installed.This resulted in the pins within the j11 connector not correctly aligning with the membrane tail tracks and the shock key line remaining open circuit.A 360p device has no shock button, and the shock key line is tied to ground via track 8 and track 9 on the membrane tail.These tracks remaining open circuit had resulted in the device failing self-tests due to a shock key error and the reported fault of ¿device service required¿ prompt.The fault was resolved after correctly reinstalling the membrane into the j11 connector.Heartsine records indicate the device had performed to specification throughout testing on the 2nd may 2018, this would indicate the membrane tail had made sufficient contact with the j11 pins at that time.It is the policy of heartsine not to refurbish devices which have been returned from the field, after investigation, therefore this device shall be scrapped and replaced with another device of the same model.

Event Description

There was no patient involved.Red status indicator flashing and warning prompt heard.

• Brand Name: PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED
• MDR Report Key: 7633077
• MDR Text Key: 112289429
• Report Number: 3004123209-2018-00425
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 80514-000062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1