MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 350P

Device Problem Noise, Audible (3273)

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

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

Upon receipt, the device auditory speech prompts were issued loudly and audibly.However, there was notable distortion in the speech prompts.The fault was attributed to a faulty speaker and could not be replicated with a known good speaker installed.Heartsine further evaluated the device and determined that the fault was attributed to the speaker, however, further root cause could not be established.The device was scrapped by heartsine and the customer was provided with a replacement device.

Event Description

The distributor contacted heartsine to report a non-critical issue with their customer's device.Upon evaluation of the customer¿s device, heartsine observed that the device was emitting distorted audio prompts.This may lead to an inability understanding how to use the device correctly, which could prevent or delay defibrillation therapy.There was no report of patient use associated to the reported event.

• Brand Name: PACKAGE, 350P,PP03J,JA,350-STR-JA-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: 16989011
• MDR Text Key: 316289777
• Report Number: 3004123209-2023-00061
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2023

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-JA-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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