MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number 350P

Device Problems Failure to Power Up (1476); No Visual Prompts/Feedback (4021)

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

Event Date 05/17/2023

Event Type  malfunction  

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 turn on.In this state, the device may be unable to deliver defibrillation therapy if needed.There was no patient involvement reported during the event.

Manufacturer Narrative

The device was not returned for evaluation, however the pad-pak was returned to heartsine, the reported problem was confirmed.The pad-pak was found to be depleted.The cause of the reported issue could not be determined.H3 other text : device not returned to manufacturer.

Event Description

The customer contacted heartsine to report that their device would not turn on.In this state, the device may be unable to deliver defibrillation therapy if needed.There was no patient involvement reported during the event.

• Brand Name: UNKNOWN_MEDICAL - BELFAST_PRODUCT
• 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: dara friedman ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 17217455
• MDR Text Key: 318041715
• Report Number: 3004123209-2023-00081
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/20/2023

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: UNK_BEL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2017
• 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