MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 300P AND PAD PAK; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM

Device Problem Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

There was no patient involved in this event.The device was found to be switching itself on automatically.

Manufacturer Narrative

Routine testing confirmed that this device was installed by the customer in (b)(6) 2010 and performed to specification up to the last log entry on (b)(6) 2012.The device failed a self-test due to a low battery on the (b)(6) 2012 and remained in fault mode until (b)(6) 2013 when the device passed a self-test.An increase in voltage suggests a further pad-pak was installed during this time.Multiple manual power ups of ten minutes duration were observed in the device memory between (b)(6) 2014 and the last log entry on (b)(6) 2015.The pad-pak became depleted during this time and a further pad-pak was installed.It is reasonable to conclude that devices returned for the reported fault may be attributed to membrane failure.The ten minute time outs, the measurements taken and the excess current drain would confirm a failing membrane.During investigation the right pad-placement leds were observed tot be lit in time with the chest leds while the left pad-placement leds were observed to be lit in time with the red status led, this is a further symptom of a membrane failure.The fault could not be replicated with a new membrane fitted.The pad-pak, which contains the electrodes and batteries, is labeled for single use but the samaritan pad (b)(4) devices are for multi-use, which is why the "unknown" box has been checked in of this report.

• Brand Name: HEARTSINE SAMARITAN 300P 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 9ED; 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: 4837858
• MDR Text Key: 16851406
• Report Number: 3004123209-2015-00647
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• 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: 300P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0124-2013
• Patient Sequence Number: 1