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 Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2015058.(b)(4).
Event or Problem Description
Status led is not blinking.(the readiness indicator is not blinking on this device).No patient involvement.
Event or Problem Description
Status led is not blinking.(the readiness indicator is not blinking on this device.) no patient involvement.
Additional Manufacturer Narrative
The device history records for the sam 450p device 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 23rd november 2017.Upon receipt the green status indicator failed to illuminate, as per the reported fault.Visual inspection revealed the membrane tail was misaligned with the j11 connector, which had resulted in no connection between track 5 and its associated pin on j11.As no fault was identified on the j11 connector, and the fault could not be replicated after correctly reinstalling the membrane within the connector, this would confirm the reported failure had been due to the misalignment of the membrane tail.Heartsine records indicate the device had performed to specification throughout sam 450p final unit test, on the (b)(6) 2017, indicating the membrane tail had made sufficient contact with the j11 pins at this time.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-STR-US-10
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; IE BT3 9ED
• MDR Report Key: 9811033
• Report Number: 3004123209-2020-00056
• Device Sequence Number: 948099
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 06/26/2020

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: 05/25/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1