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

Model Number 350P

Device Problem Inappropriate Audible Prompt/Feedback (2280)

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

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault as upon receipt the device was found to be giving incorrect adult patient prompts with a pedi-pak installed.This fault was attributed to the reed switch.The device was scrapped by heartsine and the customer was provided with a replacement device.

Event Description

A distributor contacted heartsine to report that a customer¿s device was emitting pediatric voice prompts when an adult pad is inserted.As patient impedance increases, the sensing of a child patient when an adult pad-pak is inserted will likely result in a reduced shock energy being delivered to the patient.As a result, wrong defibrillation therapy may be delivered.There was no report of patient use associated to the reported event.

Event Description

A distributor contacted heartsine to report that a customer¿s device was emitting pediatric voice prompts when an adult pad is inserted.As patient impedance increases, the sensing of a child patient when an adult pad-pak is inserted will likely result in a reduced shock energy being delivered to the patient.As a result, wrong defibrillation therapy may be delivered.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 return the device was found to be giving incorrect adult patient prompts with a pedi-pak installed, the measurements taken would indicate a failure of the reed switch.The reported fault was attributed to a reed switch failure.The device was scrapped by heartsine and the customer was provided with a replacement device.

• Brand Name: PACKAGE, 350P, PP03, ES, 350-STR-ES-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: 15705314
• MDR Text Key: 302934647
• Report Number: 3004123209-2022-00142
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• 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-ES-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• 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