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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2020

Event Type  malfunction  

Event Description

There was no patient involved in this event device switching on automatically, memory full device service required.

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 tests had been successfully completed.The sam 300p passed ¿out qat from heartsine technologies on the(b)(6) 2009.Membrane failure.The random nature of the events stored in the memory and the 10 minute timeouts, would suggest the device was switching on automatically.Experience has shown that it is reasonable to conclude that these symptoms may be attributed to a membrane failure.The returned sam 300p is now outside of its warranty period and will be scrapped.

Event Description

There was no patient involved in this event device switching on automatically, memory full device service required.

• 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: 10579673
• MDR Text Key: 208749072
• Report Number: 3004123209-2020-00300
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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: 09/21/2020
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0124-2013
• Patient Sequence Number: 1