MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 300P AND PAD-PAK; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number UNK_BEL

Device Problems Device Remains Activated (1525); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2018

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4).Heartsine technologies ltd (manufacturer) is submitting the report on behalf of (b)(4).

Event Description

There was no patient involved in this event.Device will not switch off using green button.

Manufacturer Narrative

The device history records for the sam 300p device and pad-pak were reviewed and this confirmed that all manufacturing and quality checks and test had been successfully completed.The sam 300p passed ¿out qat from heartsine technologies on the (b)(6) 2012.Corrosion was observed on and inside the device, including on track 13 (on_button) of the membrane tail.This had subsequently prevented the device from powering off, as per the reported fault.The corrosion would indicate the device had been subject to adverse storage conditions.Furthermore, multiple 10-minute timeouts were observed in the history log, which had depleted multiple pad-paks, including the returned pad-pak.During investigation the device was witnessed switching on automatically, which was attributed to the failure of the membrane.The faults could not be replicated with a new membrane fitted.This would confirm a failure of the returned membrane.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 a sam 350p.

Event Description

There was no patient involved in this event.Device will not switch off using green button.

• Brand Name: HEARTSINE SAMARITAN 300P AND PAD-PAK
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED
• MDR Report Key: 7901164
• MDR Text Key: 121452724
• Report Number: 3004123209-2018-00584
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K014067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• 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: 09/27/2018
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1