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 Device Alarm System (1012); Electrical /Electronic Property Problem (1198)

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

Event Date 10/23/2020

Event Type  malfunction  

Event Description

Device has a red light was flashing.There was no patient involved in this event.

Event Description

Device has a red light was flashing.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 review revealed no rework was conducted and no concessions/deviations related to the issue were identified.The sam 350p passed ¿out qat from heartsine technologies on the 10 may 2017.A visual inspection of the device revealed no apparent defects.After further investigation it was found that the reported fault could be attributed to the failure of failure of component q45, resulting in a flashing red status led, as per the reported fault.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 new sam 350p device.

• 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: 10768998
• MDR Text Key: 215571909
• Report Number: 3004123209-2020-00343
• 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): Y
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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: 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: 11/09/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1