MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD 360P DUTCH DEVICE AND 1 PAD-PAK-03; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 360-STR-NL-10

Device Problems No Audible Prompt/Feedback (2282); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2015058.(b)(4).

Event Description

No voice prompts from the device when activated.No patient involvement.

Manufacturer Narrative

The device history records for the sam 360p device were reviewed and this confirmed that all manufacturing and quality checks and test had been successfully completed.The review revealed no rework was conducted and no concessions/deviations related to the issue were identified.The sam 360p passed ¿out qat from heartsine technologies on the 31st october 2016.During the investigation, the speaker was measured and was found to have failed.This had resulted in the device failing to issue audio prompts, as per the reported fault.This sam 360p had been tested and passed h017-014-103 on the 31st october 2016.This would indicate that the speaker assembly was working at this time before deteriorating after despatch from heartsine.Failure of the returned speaker may have been due to a process defect during the manufacture of the speaker assembly resulting in a latent failure.Alternatively, the fault may have occurred due to the device being subject to external mechanical influences (i.E.Vibrations or impact).The failure of the speaker did not affect the unit¿s ability to successfully deliver the test therapy sequence, as demonstrated during the investigation, as the device continued to prompt therapy via the instructional leds.It is the policy of heartsine not to refurbish devices which have been returned from the field, after investigation, therefore this device shall be scrapped and replaced with a sam 360p.

Event Description

No voice prompts from the device when activated.No patient involvement.

• Brand Name: 360P DUTCH DEVICE AND 1 PAD-PAK-03
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; IE BT3 9ED
• MDR Report Key: 9811031
• MDR Text Key: 193434154
• Report Number: 3004123209-2020-00054
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 360-STR-NL-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1