MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-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 12/14/2022

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 stryker to report that their device failed to power on.In this state, the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported during the event.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault.Upon receipt, the device was powered on, and the green status led flashed alongside a constantly activated failure chirp, which would account for the reported 'high-pitched noise.' furthermore, the device failed to power off via the on/off button.These faults were attributed to corrosion on multiple tracks of the membrane tail.The corrosion on the usb contact collars, membrane tail, and within the membrane panel would indicate the device had been stored outside the indicated conditions.Heartsine scrapped the device, and the customer received a replacement device.

Event Description

The customer contacted stryker to report that their device failed to power on.In this state, the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported during the event.

• Brand Name: PACKAGE,350P,PP01,EN,350-STR-US-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: todd bandy ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 16071848
• MDR Text Key: 308480345
• Report Number: 3004123209-2022-00174
• Device Sequence Number: 1
• Product Code: NSA
• UDI-Device Identifier: 05060167120671
• UDI-Public: 05060167120671
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

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: 350-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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