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

Catalog Number	80515-000002
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2015058.Heartsine technologies ltd (manufacturer) is submitting the report on behalf of heartsine technologies llc (importer).
Event or Problem Description
No status indicator device will not switch on even with another pad-pak.Reportable us only.
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 green status led was failing to illuminate, as per the reported fault.A fractured solder joint on the status_led_green line of the j12 connector had resulted in the track remaining open circuit, resulting in the failure of the led to illuminate.The fault could not be replicated after the solder joint was reflowed.This confirmed the failure had been due to the fractured solder joint.Heartsine records indicate the device had performed to specification throughout out qat on the (b)(6) 2017, where the operation of the green status led is verified.This would therefore indicate the solder joint had become fractured after this time.Furthermore, the reported fault of the ¿device will not switch on¿ could not be confirmed.Information from the device memory showed the device had not been successfully power cycled since the date of installation on the (b)(6) 2018.However, the device was power cycled multiple times throughout the investigation without fault.No measurable fault was found on the membrane or elsewhere on the device that would indicate an issue with the on/off functionality.However, given the fractured solder joint identified during investigation, it is possible that a similar issue had resulted in the inability to power on the device.The device was temperature cycled between 0-50°c for 48 hours while performing a self-test every 20 minutes.Additional stress testing was carried out at 50°c 95%rh for 5 days while performing a self-test every 20 minutes.This combined testing equates to approximately 9.5 years of normal use without fault.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 new sam 450p.
Event or Problem Description
No status indicator device will not switch on even with another pad-pak.Reportable us only.

• 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
• MDR Report Key: 8137020
• Report Number: 3004123209-2018-00725
• Device Sequence Number: 10817000
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• Combination Product (Y/N): N
• 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): 06/17/2019

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 Catalogue Number: 80515-000002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1