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

Catalog Number	80515-000002
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2018
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
Device service required prompt.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)2018.A fractured joint on j12 pin 14 (key 3) of the membrane pba resulted in the device failing self-tests due to the device not powering up in 450p cpr advisor mode.These self-test fails occurred between the (b)(6)2018 and the(b)(6)2018.The user would have been alerted with a ¿warning, device service required¿ prompt and a flashing red status led, as per the reported fault.The device successfully passed final unit test, h041-014-004, on the (b)(6)2018.The device successfully passed all weekly auto self-tests from the(b)(6)2018 up to the (b)(6)2018.Therefore, it is assumed the solder joint was making sufficient contact during these times.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 another device of the same model.
Event or Problem Description
Device service required prompt.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
• MDR Report Key: 8100415
• Report Number: 3004123209-2018-00709
• Device Sequence Number: 13789579
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 06/28/2019
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 11/25/2018
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1