MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM 350P

Device Problems No Audible Prompt/Feedback (2282); Audible Prompt/Feedback Problem (4020)

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

Event Date 09/06/2020

Event Type  malfunction  

Event Description

Sam 350p defibrillator has no voice prompts during or after power up.The green led flashes every 5 seconds.There was no patient involved in this event.

Manufacturer Narrative

The device history records for the sam 350p device and pad-pak were reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed.The sam 350p passed ¿out qat from heartsine technologies on the 15th may 2019.During the investigation, the device was issuing no audio prompts as per the reported fault.The failure of the speaker did not prevent the device from delivering shock therapy, as demonstrated during the investigation, as the device continued to prompt 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 350p.

Event Description

Sam 350p defibrillator has no voice prompts during or after power up.The green led flashes every 5 seconds.There was no patient involved in this event.

• Brand Name: PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 10611782
• MDR Text Key: 219199122
• Report Number: 3004123209-2020-00312
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• Combination Product (y/n): N
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SAM 350P
• Device Catalogue Number: 350-BAS-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1