MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10,BEL; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 350P

Device Problem Inappropriate Audible Prompt/Feedback (2280)

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

Event Date 03/30/2023

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 customer contacted heartsine to report that their device operated with the incorrect language.Incorrect language may lead to an inability to understand the device, which may prevent or delay defibrillation therapy.There was no report of patient use associated to the reported event.

Event Description

The customer contacted heartsine to report that their device operated with the incorrect language.Incorrect language may lead to an inability to understand the device, which may prevent or delay defibrillation therapy.There was no report of patient use associated to the reported event.

Manufacturer Narrative

Heartsine has made multiple attempts to contact the customer regarding the status of their device, but no response has been received from the customer.The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time.The cause of the reported issue could not be determined.If the device is returned to the manufacturer the investigation will be reopened.H3 other text : device not returned for evaluation.

Event Description

The customer contacted heartsine to report that their device operated with the incorrect language.Incorrect language may lead to an inability to understand the device, which may prevent or delay defibrillation therapy.There was no report of patient use associated to the reported event.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault as upon receipt the device was found to emitting incorrect language voice prompts.This fault was attributed to incorrect program settings at the time of manufacture.The device was scrapped by heartsine and the customer was provided with a replacement device.

• Brand Name: PACKAGE,350P,PP01,EN,350-STR-US-10,BEL
• 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: 16781609
• MDR Text Key: 313714166
• Report Number: 3004123209-2023-00041
• Device Sequence Number: 1
• Product Code: NSA
• UDI-Device Identifier: 05060167120671
• UDI-Public: 05060167120671
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2023

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-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/17/2023; 09/06/2023
• Supplement Dates FDA Received: 06/02/2023; 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• 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