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

Catalog Number UNK_BEL

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

There was no patient involved in this event.Device switching on automatically and prompting memory full.

Manufacturer Narrative

The device history records for the sam 300 device was reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed.The sam 300 passed ¿out qat from heartsine technologies on the (b)(6) 2005.The device was returned with the reported fault of ¿memory full prompts¿.Further information from the reported complaint confirmed that the user had been regularly powering on the device to check the status of the battery.From device installation the device records a total of 63 log entries, which included 29 manual power cycles and 34 low battery fails.The large quantity of manual power ons in combination with the low battery fails had filled the device memory over the course of 11 years from installation, resulting in ¿memory full¿ prompts from the (b)(6) 2016.Additionally, the investigation found no fault with the device during testing at heartsine.The memory full prompt indicates the device is no longer able to record ecg/icg information but does not indicate a fault.The device can still analyse and deliver a shock if required, as demonstrated during the investigation.The returned sam 300 device is now out of warranty and will be scrapped.

Event Description

There was no patient involved in this event.Device switching on automatically and prompting memory full.

• 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; EI BT3 9ED
• MDR Report Key: 10611780
• MDR Text Key: 219376876
• Report Number: 3004123209-2020-00311
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/29/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0124-2013
• Patient Sequence Number: 1