MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD SAMARITAN PAD TRAINER 350P - PORTUGUESE (2 MIN CPR); AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 350P

Device Problem Key or Button Unresponsive/not Working (4063)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

Heartsine has received the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.Heartsine contacted the customer to request additional information on the patient.The customer provided heartsine with the available patient information.Patient fields in which information is not provided were intentionally left blank.

Event Description

The distributor contacted heartsine to report that their customer's device did not work during a rescue operation.It was reported that the shock key was stuck.The patient associated with the reported event did not survive.

Manufacturer Narrative

Heartsine evaluated the customer's device but was unable to duplicate the reported issue.No measurable fault was identified and the device performed to specification during evaluation.These observations could suggest that the issue was due to user pressing the shock button during a manual power-on.A clinical review was performed and it was determined that the device did not contribute to the reported event as the patient was in a non-shockable rhythm.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 did not work during a rescue operation.It was reported that the shock key was stuck.The patient associated with the reported event did not survive.

• Brand Name: SAMARITAN PAD TRAINER 350P - PORTUGUESE (2 MIN CPR)
• 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: 17596402
• MDR Text Key: 321658629
• Report Number: 3004123209-2023-00111
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 350P
• Device Catalogue Number: 350-STR-PO-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2019
• 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
• Patient Outcome(s): Death
• Patient Sex: Female