MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 500P AND PAD PAK; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM

Device Problems No Audible Alarm (1019); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

There was no patient involved in this event.No sound.

Manufacturer Narrative

(b)(4).The device history records for the returned sam 500p device were reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed prior to the despatch of the sam 500p from heartsine technologies, belfast on 27th january 2015.On receipt of the device the history and memory logs were downloaded.The history log for this device showed that the pad-pak was first installed on (b)(6) 2015 and performed to specification up until (b)(6) 2017.The user accessible memory was erased on (b)(6) 2017.The device was tested on the calibrated impulse defibrillator analyser and delivered a test shock without fault.The device was disassembled to investigate and no defects were found.The device language was changed to us english.The language change was successful and all voice prompts were given as expected.This indicates an issue had developed with the digital speech chip.The fault was replicated by beginning a language change then immediately removing the usb cable during the speech erase sequence.The device was then power cycled with no audio prompts.This suggests a failed language change resulted in the reported fault.The pad-pak, which contains the electrodes and batteries, is labelled for single use but the samaritan pad 300 and 300p devices are for multi-use.

• Brand Name: HEARTSINE SAMARITAN 500P AND PAD PAK
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast, united kingdom BT3 9 ED; UK BT3 9ED
• Manufacturer (Section G): HEARTSINE TECHNOLOGIES LLC - 2032757 - IMPORTER; mr. james mcguinness; 121 friends lane, suite 400; newton PA 18940
• Manufacturer Contact: james mcguinness ; manufacturer; 203 airport road west; belfast, northern ireland BT3 9-ED ; UK BT3 9ED
• MDR Report Key: 6840886
• MDR Text Key: 84960080
• Report Number: 3004123209-2017-00975
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/30/2017,10/19/2017

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: Lay User/Patient
• Device Model Number: SAM
• Device Catalogue Number: 500P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2017
• Device Age: 2 YR
• Date Report to Manufacturer: 08/30/2017
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/04/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1