MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM 350P

Device Problems Self-Activation or Keying (1557); Failure to Shut Off (2939)

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

Event Date 09/14/2020

Event Type  malfunction  

Event Description

There was no patient involved in this event it was reported that the device switching on automatically.Then the audible prompts fade to a whisper and the device will not switch off.

Manufacturer Narrative

The device history records for the sam 350p device was 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 8th january 2014.Upon receipt, the device was switching on upon installation of a pad-pak and could not be powered off via the on/off button, as per the reported fault.This was attributed to corrosion on track 13 (on_button) and 14 (key3_button) of the membrane tail.Furthermore, the speaker was measured and found to have failed, which had led to no audio prompts upon receipt at heartsine.Due to the corrosion observed within the device, it is likely that this was a further consequence of storage outside of the indicated conditions.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 therapy via the instructional leds.The corrosion observed on the membrane tail alongside discolouration of the rubber feet would suggest the device had been stored outside of the indicated conditions.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 another device of the same model.

Event Description

There was no patient involved in this event it was reported that the device switching on automatically.Then the audible prompts fade to a whisper and the device will not switch off.

• Brand Name: PACKAGE,350P,PP01,EN,350-STR-US-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: 10611781
• MDR Text Key: 219376787
• Report Number: 3004123209-2020-00313
• 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: distributor
• 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

• 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-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1