MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	SAM 350P
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Heartsine contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.The customer provided heartsine with the available patient information.Patient fields in which information is not provided were intentionally left blank.Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
Event or Problem Description
The customer contacted stryker to report that their ped pak had not made proper contact with the device and that consequently the device experienced a recurring loop, repeatedly playing the same voice prompt without advancing to the subsequent step.The patient associated with the reported event did not survive.The customer confirmed that the device use did not contribute to the patient outcome.
Event or Problem Description
The customer contacted stryker to report that their ped pak had not made proper contact with the device and that consequently the device experienced a recurring loop, repeatedly playing the same voice prompt without advancing to the subsequent step.The patient associated with the reported event did not survive.The customer confirmed that the device use did not contribute to the patient outcome.
Additional Manufacturer Narrative
Heartsine evaluated the customer' device and was unable to verify and duplicate the reported issue.The electronic records were downloaded for review.It was observed that the device functioned according to specifications.The pedi-paks were not returned to heartsine for evaluation.Given no fault found on the device, the issue was likely due to the pedi-paks being incorrectly seated within the devices, as indicated by the customer.The cause of the reported issue was determined to be user error.A clinical review was performed and it was determined that the device use did not contributed to patient's outcome.

• Brand Name: PACKAGE,350P,PP01,EN,350-STR-US-10
• Common Device Name: 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: brian blakeslee ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 23059669
• Report Number: 3004123209-2025-00235
• Device Sequence Number: 9850392
• Product Code: NSA
• UDI-Device Identifier: 05060167120671
• UDI-Public: 05060167120671
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 350P
• Device Catalogue Number: 350-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RA2024-3540155
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Sex: Male
• Patient Weight: 5 KG