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

Model Number SAM350P

Device Problems Failure to Power Up (1476); Audible Prompt/Feedback Problem (4020)

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault.Upon return, the device could not be powered on.When insterted with a new pad-pak, the device could not be powered off due to continuous beeping.The reported fault was attributed to a failure of mosfet q37, which forms part of the on/off circuitry.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 a customer's device.During evaluation it was found that the device would not turn on.Failure to power on device may prevent or delay defibrillation, which could cause an adverse event.There was no report of patient use associated to the reported event.

• Brand Name: PACKAGE 350P, 1X PAD-PAK-03, FRENCH, 350-STR-FR-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: todd bandy ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 15047861
• MDR Text Key: 304706204
• Report Number: 3004123209-2022-00099
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SAM350P
• Device Catalogue Number: 350-STR-FR-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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