MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,450P,PP01,EN,450-BAC-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	SAM 450P
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2015058.(b)(4).
Event or Problem Description
Device doesn¿t turn on.There was no patient involved in this event.
Additional Manufacturer Narrative
The device history records for the sam 450p device and pad-pak were reviewed and this confirmed that all manufacturing and quality checks and test had been successfully completed.The sam 450p passed ¿out qat from heartsine technologies on the (b)(6) 2017.Upon receipt the device could not be powered on, as per the reported fault.The fault was attributed to a broken track 13 (on_button) on the membrane pcba.The broken track 13 (on_button) had resulted in no connection on this line and the subsequent failure of the device to power on as witnessed during the investigation.The fault could not be replicated when the broken section of track was bypassed using a wire link.This would confirm the reported failure had been due to the broken track.Information from the history log showed the device was power cycled a total of 13 times between the date on installation on the (b)(6) 2017 and the (b)(6) 2018.This would indicate that there had been continuity on track 13 (on_button) up to this date.No further manual power ons were recorded for the remaining 17 months in service which would suggest the track had became open circuit after this date.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 a sam 450p.
Event or Problem Description
Device doesn¿t turn on.There was no patient involved in this event.

• Brand Name: PACKAGE,450P,PP01,EN,450-BAC-US-10
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; IE BT3 9ED
• MDR Report Key: 9368065
• Report Number: 3004123209-2019-00417
• Device Sequence Number: 14127367
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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
• Operator of Device: No Information
• Device Model Number: SAM 450P
• Device Catalogue Number: 80515-000002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1