MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,USB,TH,350-BAS-TH-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 350P

Device Problem Inappropriate Audible Prompt/Feedback (2280)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.

Event Description

The distributor contacted heartsine to report that their device had been programmed with the incorrect language.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.

Manufacturer Narrative

Heartsine's evaluation confirmed the reported fault.Upon receipt, the device was issuing the audio advisory prompts in (us) english instead of thai, as per the reported fault.The investigation attributed this fault to an error occurring during a device language change as the device memory shows that the device language had been changed from thai to spanish (american) and then to us english on the 22nd january 2024.The device was scrapped by heartsine and the customer was provided with a replacement device.

Event Description

The distributor contacted heartsine to report that their device had been programmed with the incorrect language.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.

• Brand Name: PACKAGE,350P,PP03,USB,TH,350-BAS-TH-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: brian blakeslee ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 18761483
• MDR Text Key: 336970826
• Report Number: 3004123209-2024-00027
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 02/22/2024

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-BAS-TH-10
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2017
• 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