MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,FR,350-BAS-FR-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 80514-000270

Device Problems Self-Activation or Keying (1557); Defective Device (2588); Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Not returned yet.

Event Description

There was no patient involved.Device switches on automatically, volume starts ok then drops in volume and become in audible.

Event Description

There was no patient involved.Device switches on automatically, volume starts ok then drops in volume and become in audible.

Manufacturer Narrative

The device history records for the sam 350p 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 350p passed ¿out qat from heartsine technologies on the 17th february 2014.Multiple manual power ons were recorded in the device history between the 25th march 2016 and the 20th june 2016.These manual power ons would indicate the device was switching itself on automatically as per the reported fault.The fault was traced back to corrosion on track 13 of the membrane tail.Subsequent to clearing the corrosion on the membrane tail, the j11 measurements and the current drain returned to a level comparable with a known good unit.This would confirm a fault with the original membrane due to corrosion on the membrane tail.Furthermore, this corrosion had resulted in an 18v short circuit onto track 14 of the membrane tail.This would have caused an 18v overvoltage and permanent damage to the microprocessor u25, and resulted in the device entering cpr advisor mode, and most of the instructional leds remaining illuminated, as witnessed during the investigation.The corrosion observed on the membrane tail, would indicate the device had been subject to storage outside the indicated conditions (e.G.Exposure to high condensing humidity).However, this could not be verified by other means.Additionally, the speaker was measured and found to have failed.This had resulted in the device only giving speech prompts intermittently, as per the reported fault.The fault was traced back to an intermittent connection between the speaker coil wire to the solder point on the speaker.The device being stored outside the indicated conditions may have contributed to the failure of the speaker, however, this could not be verified by other means.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,350P,PP03,FR,350-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: 7612816
• MDR Text Key: 111439912
• Report Number: 3004123209-2018-00415
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• 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: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 80514-000270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1