MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 350P AND PAD PAK; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2017

Event Type  malfunction  

Event Description

Pad unit had low battery during usage.

Manufacturer Narrative

(b)(4).The device history records for the returned sam 350p device were reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed prior to the dispatch of the sam 350p from heartsine technologies, (b)(4) on (b)(6) 2016.The history log for this device showed that the pad-pak was first installed on (b)(6) 2016 and had performed to specification, alongside random manual power ons, up to and including the last log entry on the (b)(6) 2017.During the above period, the device was reported as being used in an sca on the (b)(6) 2017.There were 3 very short events.They appear to be simulated tests.The events were recorded on: (b)(6) 2016.A fourth patient event occurred on (b)(6) 2017.The event was 11 minutes 56 seconds.The patient did not have a shockable rhythm throughout.The event appeared to be sinus rhythm.A shock was not delivered but due to electrode artefact the algorithm reanalysed for a few seconds to ensure there was no shockable rhythm present.Chest compressions were administered intermittently at varying rates from around 120 cpm to 132 cpm.The electrodes appeared to become disconnected or removed at 4 minutes 53 seconds and there was no viewable ecg for the remainder of the event.During the time that an ecg was available for analysis it can be concluded that the device algorithm performed to specification.The user also pressed the on/off button on the device on a number of occasions towards the end of the event and on each occasion the device warned the user that the on/off button had been pressed.This is a failsafe mechanism in the device to warn the user that the on/off button may have been pressed unintentionally.The user then removed the pad-pak from the device in order to shut it down however the device was unable to enter the shutdown sequence and logged the pad-pak removal as a low battery in the memory log.

• Brand Name: HEARTSINE SAMARITAN 350P AND PAD PAK
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; canberra house; 203 airport road west; belfast, northern ireland BT3 9 ED; UK BT3 9ED
• Manufacturer (Section G): HEARTSINE TECHNOLOGIES LTD; canberra house; 203 airport road west; belfast, northern ireland BT3 9 ED; UK BT3 9ED
• Manufacturer Contact: james mcguinness ; canberra house; 203 airport road west; belfast, northern ireland BT3 9-ED ; UK BT3 9ED ; 4289093941
• MDR Report Key: 6398623
• MDR Text Key: 70027679
• Report Number: 3004123209-2017-00210
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• 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: 350P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/15/2017
• Device Age: 1 YR
• Date Report to Manufacturer: 03/09/2017
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 34 YR