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

Model Number SAM

Device Problems Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913)

Patient Problems Diabetic Ketoacidosis (2364); No Patient Involvement (2645)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4).Heartsine technologies ltd is submitting the report on (b)(4).Device not yet returned.

Event Description

No patient was involved in this event.Device observed switching on automatically.

Manufacturer Narrative

Exemption number e2015058.Heartsine technologies ltd (manufacturer) is submitting the report on behalf of heartsine technologies llc (importer).The device history records for the returned sam 300p device was reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed prior to the despatch of the sam 300p from heartsine technologies, belfast on the (b)(6) 2009.The data obtained from the device showed evidence that the device was switching itself on automatically for 10 minute durations between (b)(6) 2017.Experience has shown that it is reasonable to conclude that these symptoms may be attributed to membrane failure, 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, which is why the "unknown" box has been checked in section 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 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: 6586929
• MDR Text Key: 75925136
• Report Number: 3004123209-2017-00482
• 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,user facility
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/23/2017,08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• 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: 300P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2017
• Device Age: 8 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/23/2017
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2009
• 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