MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, 1X PAD-PAK-03, GERMAN, 350-STR-DE-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 350P

Device Problem Failure to Deliver Shock/Stimulation (1133)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

The customer contacted heartsine to report that their device could not deliver shock energy.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient involvement reported with the event.

Manufacturer Narrative

Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.

• Brand Name: PACKAGE, 350P, 1X PAD-PAK-03, GERMAN, 350-STR-DE-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: 18955318
• MDR Text Key: 338285450
• Report Number: 3004123209-2024-00032
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 350P
• Device Catalogue Number: 350-STR-DE-10
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2021
• 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