MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,360P,PP01,EN,360-STR-US-10; DEVICE: AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	SAM 360P
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, stryker observed that the device's right pad led failed to illuminate.This may cause confusion to pad placement, which may prevent or delay defibrillation.As a result, defibrillation therapy may be unavailable, if it was needed.
Additional Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault as upon receipt the device's green status indicator was extinguished, as per the reported fault.Additionally, the right-hand side pads placement icon led did not light.This fault was attributed to a misaligned membrane tail.The device was scrapped by heartsine and the customer was provided with a replacement device.

• Brand Name: PACKAGE,360P,PP01,EN,360-STR-US-10
• Common Device Name: DEVICE: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• Manufacturer (Section G): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• Manufacturer Contact: todd bandy ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 14691775
• Report Number: 3004123209-2022-00087
• Device Sequence Number: 5327350
• Product Code: MKJ
• UDI-Device Identifier: 05060167120688
• UDI-Public: 05060167120688
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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: Lay User/Patient
• Device Model Number: SAM 360P
• Device Catalogue Number: 360-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown