MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,500P,PP03,INTL EN,500-BAS-SP-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 80515-000035

Device Problems Device Maintenance Issue (1379); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Not returned yet.

Event Description

There was no patient involved.Device service required.

Event Description

There was no patient involved.Device service required.

Manufacturer Narrative

The device history records for the sam 500p 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 500p passed ¿out qat from heartsine technologies on the 11th september 2013.Y1 is an integral component within the rtc circuitry.During the investigation, the crystal was found to have no measurable output, indicating a failure of the crystal.This prevented the rtc from functioning correctly and resulted in a number of failures, including an incorrect date and time stored on device, an inability to synchronise to pc date and time, and a ¿device service required¿ prompt as per the reported fault.All faults were rectified subsequent to a new crystal being installed.The device successfully performed all weekly auto self-tests up to the 15th november 2015.Therefore, it is concluded the component failed after this date.The device was still able to deliver shock therapy as demonstrated during the investigation.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.

• Brand Name: PACKAGE,500P,PP03,INTL EN,500-BAS-SP-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED
• MDR Report Key: 7497677
• MDR Text Key: 107695960
• Report Number: 3004123209-2018-00318
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 80515-000035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1