MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,1X PAD-PAK-03, DUTCH, 350-STR-NL-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 350P

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

Upon receipt, the sternum pogo pin was found to be stuck inside its barrel and it remained within its barrel upon rotation of the device.Corrosion was seen on the pogo-pin which would indicate that the device was stored outside of the indicated conditions.The corrosion on the pogo-pin had caused the pin to become stuck inside its barrel.This had resulted in the pogo pin failing to make a connection with the sternum terminal on the pad-pak.This would have caused the device to not detect an impedance or progress past the apply pads prompts.The fault was attributed to a damaged pogo-pin due to storage outside of the indicated conditions.The device was scrapped by heartsine and the customer was provided with a replacement device.

Event Description

A distributor contacted heartsine to report a non-critical issue with their device.Upon evaluation of the customer¿s device, heartsine observed a pogo pin failure.A pogo pin failure may prevent the device from connecting with the pad-pak.This may result in the device failing to power on.This may prevent or delay defibrillation therapy.There was no report of patient use associated to the reported event.

• Brand Name: PACKAGE, 350P,1X PAD-PAK-03, DUTCH, 350-STR-NL-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• Manufacturer (Section G): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• Manufacturer Contact: dara friedman ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 17376867
• MDR Text Key: 320484961
• Report Number: 3004123209-2023-00099
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2023

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: Lay User/Patient
• Device Model Number: 350P
• Device Catalogue Number: 350-STR-NL-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1