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	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/05/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Exemption number e2015058.(b)(4).
Event or Problem Description
There was a patient involved in this event.A samartian 450p device was used during an alleged sca in the usa.The responder removed pads from device and placed on the patient.It was alleged that the unit kept cycling through the prompts and would not progress to analyze for shock therapy.The responder used an alternative device to provide therapy.Customer stated that the patient did not survive.
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 19th may 2015.The device was powered on and the user was issued with the advisory speech prompts.The electrode pads were briefly detected as being placed 1 minute and 26 seconds after power on.However, power appears to have been removed from the device shortly after resulting in no analysis of the patient¿s heart rhythm.This may suggest the pad-pak was removed or had been incorrectly seated within the device.The device was immediately powered on again, but the electrode pads were not detected as being attached.The device was subsequently powered off after 1 minutes and 5 seconds.During the investigation, the device was found to be correctly measuring impedance throughout the range even under the stress of elevated temperature.In the absence of the patient, the investigation was unable to replicate the reported fault.The fault may have been due to a number of things, for example, pad positioning excessive hair or an incorrectly seated pad-pak.This device shall by retained by heartsine as per complaint handling procedure h001-003-080.
Event or Problem Description
There was a patient involved in this event.A samartian 450p device was used during an alleged sca in the usa.The responder removed pads from device and placed on the patient.It was alleged that the unit kept cycling through the prompts and would not progress to analyze for shock therapy.The responder used an alternative device to provide therapy.Customer stated that the patient did not survive.

• 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: 9652391
• Report Number: 3004123209-2020-00021
• Device Sequence Number: 19438678
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/31/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death