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 Code	No Patient Involvement (2645)
Date of Event	07/01/2019
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
Device beeping red status indicator.There was no patient involved in this event.
Event or Problem Description
Device beeping red status indicator.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 15th february 2019.Upon receipt the device was failing self- tests due to a speech chip label mismatch error.A fractured solder joint on the key3_butt on line of the j12 connector had resulted in the track remaining open circuit, leading to the failed self-tests.The user would have been alerted with a ¿warning, device service required¿ prompt alongside a flashing red status led and failure chirp, as per the reported fault.The fault could not be replicated after the solder joint was reflowed.This confirmed the failure had been due to the fractured solder joint.Information from heartsine records and the device memory indicate the device had performed to specification during out qat on the 15th february 2019 but failed on installation on the 7th july 2019.This would indicate the solder joint had become fractured between these dates.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.

• 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: 8780092
• Report Number: 3004123209-2019-00253
• Device Sequence Number: 16724731
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/30/2019

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: 08/19/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1