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

Catalog Number 80515-000084

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

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.Adult prompt with child pad-pak.

Event Description

There was no patient involved.Adult prompt with child pad-pak.

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 29th june 2016.The reed switch was measured and found to have failed.This had resulted in the device failing to enter child patient mode upon insertion of a pedi-pak and had resulted in the reported fault.The operation of the reed switch was tested as part of the final unit test specification, h017-014-204, at heartsine on the 29th june 2016.Therefore, it is concluded the reed switch failed after despatch from heartsine.In the absence of a functioning paediatric system, general advice is to administer adult level shocks to a paediatric patient.The device was still capable of delivering therapy as demonstrated during the course of 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,FR,500-BAS-FR-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED
• MDR Report Key: 7457385
• MDR Text Key: 106393263
• Report Number: 3004123209-2018-00279
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 80515-000084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1