MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,HE,350-STR-HE-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 350P

Device Problems Failure to Power Up (1476); No Audible Prompt/Feedback (2282)

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

Event Date 12/17/2023

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

A customer contacted heartsine to report that their device would not provide audio prompts.Without audio prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no report of patient use associated to the reported event.

Event Description

A customer contacted heartsine to report that their device would not provide audio prompts.Without audio prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no report of patient use associated to the reported event.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault as upon return the device could not be powered on.The reported fault was attributed to contaminate on the on/off dome due to storage outside of the indicated conditions.Corrosion and moisture marks were also identified on the usb contact collars and device casing respectively.These observations would suggest that the device was stored outside of the indicated conditions.The device was scrapped by heartsine.Furthermore, it was later reported to heartsine that the device had been used in a patient involved event.Information within the communication log indicates that the patient was found ¿hours after¿ they had died.The customer also stated that the device was stored outside for prolonged periods, which may suggest that the device was stored outside of the indicated conditions.

• Brand Name: PACKAGE,350P,PP03,HE,350-STR-HE-10
• 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: brian blakeslee ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 18510267
• MDR Text Key: 333247681
• Report Number: 3004123209-2024-00005
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 05/01/2024
• 2 Devices were Involved in the Event: 1 2

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-HE-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/17/2023
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• 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