MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, PP03, IT, 350-STR-IT-10; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number 350P

Device Problem Inappropriate Audible Prompt/Feedback (2280)

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

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

Heartsine has requested the 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 customer's device voice prompted "child patient" with an adult pad-pak.In this state, wrong defibrillation therapy may be delivered.There was no patient involvement reported during the 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 return.

Event Description

The distributor contacted heartsine to report that their customer's device voice prompted "child patient" with an adult pad-pak.In this state, wrong defibrillation therapy may be delivered.There was no patient involvement reported during the event.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault as upon receipt the device was found to be unable to switch on.This fault was attributed to a failure of the sw1 reed switch.The reed switch was visually inspected, and the switch contacts were observed to be closed without the presence of a magnetic field.This would account for the device issuing incorrect child patient prompts with an adult pad-pak.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 customer's device voice prompted "child patient" with an adult pad-pak.In this state, wrong defibrillation therapy may be delivered.There was no patient involvement reported during the event.

• Brand Name: PACKAGE, 350P, PP03, IT, 350-STR-IT-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS
• 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: 17170276
• MDR Text Key: 318010030
• Report Number: 3004123209-2023-00077
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup,Followup
• Report Date: 02/14/2024

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-STR-IT-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 08/03/2023; 02/09/2024
• Supplement Dates FDA Received: 08/04/2023; 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2014
• 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