MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 450P, PP03J, JA, 450-BAS-JA-08; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number	80515-000128
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/13/2019
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 service required prompt.There was no patient involved in this event.
Additional Manufacturer Narrative
The device history records for the sam 450p device was 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 25th june 2019.Information from the history log showed the device had failed the rtc tick test during every self-test prior to receipt at heartsine.The user would have been alerted with ¿warning, device service required¿ prompts as per the reported fault.Upon receipt, the pad clock was out of synchronization by over two months and the vl flag had been triggered.These symptoms would indicate an interruption of the rtc had occurred.Throughout the investigation, the device passed all self-tests and the pad clock incremented without fault.No measurable fault was found anywhere on the rtc circuitry, including rtc u20, bt1 coin cell, y1 crystal oscillator or its loading capacitors.The integrity of the rtc circuitry was verified by temperature cycling the device between 0-50°c for 48 hours.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 therefore possible that a fault had been present on the device which had interrupted the rtc but had cleared by the time of investigation.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
Device service required prompt.There was no patient involved in this event.

• Brand Name: PACKAGE, 450P, PP03J, JA, 450-BAS-JA-08
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED
• MDR Report Key: 8924684
• Report Number: 3004123209-2019-00297
• Device Sequence Number: 2128951
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• Combination Product (Y/N): N
• 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): 10/25/2019

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: 80515-000128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1