MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HDF3500 AND PAD-PAK; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number UNK_BEL

Device Problems Unintended Power Up (1162); Self-Activation or Keying (1557); Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

There was no patient involved in this event.The device turns on automatically and guidance plays.

Manufacturer Narrative

The device history records for the hdf-3500 device and pad-pak were reviewed and this confirmed that all manufacturing and quality checks and test had been successfully completed.The review revealed no rework was conducted and no concessions/deviations related to the issue were identified.The hdf-3500 passed ¿out qat from heartsine technologies on the (b)(6) 2018.Failure of mosfet q37.During the investigation, the unit was witnessed switching on automatically, as per the reported fault.The fault was attributed to a failure of mosfet q37, which forms part of the on/off switching circuitry.The fault had also drawn excess through resistor r166, resulting in a secondary failure of r166.The fault could not be replicated after replacing q37.This confirmed the failure of this component.Information from the device memory showed multiple manual power ons of 10-minute duration from the (b)(6) 2020, which would suggest the failure had occurred at this time.The high quantity of power ons had filled the memory by the (b)(6) 2020 and depleted the returned pad-pak, resulting in low battery fails from the (b)(6) 2020.The user would have been alerted with ¿warning, low battery, memory full¿ prompts, alongside a flashing red status led and failure chirp.It is a policy of heartsine to not refurbish devices that have been returned from the field, therefore this device shall be retained and replaced with a hdf-3500.

Event Description

There was no patient involved in this event.The device turns on automatically and guidance plays.

• Brand Name: HDF3500 AND PAD-PAK
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 10492949
• MDR Text Key: 205967806
• Report Number: 3004123209-2020-00286
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_BEL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1