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

Model Number	SAM 450P
Medical Device Problem Codes	Device Alarm System (1012); Activation Problem (4042)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
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 tests had been successfully completed.The sam 450p passed ¿out qat¿ from heartsine technologies on the 5th september 2017.Upon receipt, the device was issuing, ¿warning, device service required¿ prompts as per the reported fault.Further investigation revealed that the negative leg of the coin cell had broken off from the solder joint of the pcba, which had removed the coin cell from circuit.Information from the history log showed that the rtc faults occurred after the 25th november 2018, indicating that the coin cell had become detached after this date.Due to the nature of how the negative leg had broken off the component, i.E.-ve solder joint still intact, the damage had likely occurred due to an impact as evidenced by the displacement of a rubber foot from the lower-case and scratches near the speaker housing.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-STR-US-10
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 10592193
• Report Number: 3004123209-2020-00308
• Device Sequence Number: 2385986
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 450-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1