MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, 1X PAD-PAK-03, DANISH, 350-STR-DA-10; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number 350P

Device Problem Failure to Power Up (1476)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

The customer contacted heartsine to report that their device would not power on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.

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 would not power on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.

Manufacturer Narrative

Heartsine evaluated the customer's device and verified the reported issue.Heartsine determined that the cause of the reported issue was due to a failure of the +ve pogo-pin.It was noted through the device electronic records that the device was stored outdoors.This may have contributed to the pogo-pin failure.The customer received a replacement device and the returned device was scrapped by heartsine.

• Brand Name: PACKAGE, 350P, 1X PAD-PAK-03, DANISH, 350-STR-DA-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: 18262021
• MDR Text Key: 329667157
• Report Number: 3004123209-2023-00170
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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-DA-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2018
• 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