MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PAD-PAK-01; COMBINED, SINGLE USE, BATTERY AND ELECTRODE UNIT

Model Number	PAD-PAK-01
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
In response to a product field action, the customer contacted heartsine to report the pad-pak's locator pin is bent.This issue can lead to a failure to detect when a patient is connected or could cause the device to lose power during operation.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
The pad-pak was not returned to heartsine for evaluation.The customer has been instructed to dispose of the affected unit following local waste disposal regulations.The customer was sent a replacement pad-pak.A capa investigation determined multiple potential causes of the fault, both internal and external to stryker manufacturing processes, the primary root cause was determined to be pressure applied onto the locator pins during handling/packaging.

• Brand Name: PAD-PAK-01
• Common Device Name: COMBINED, SINGLE USE, BATTERY AND ELECTRODE UNIT
• 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: 24413385
• Report Number: 3004123209-2026-00310
• Device Sequence Number: 10569786
• Product Code: MKJ
• UDI-Device Identifier: 05060167120466
• UDI-Public: 05060167120466
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 02/23/2026

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: PAD-PAK-01
• Device Catalogue Number: PAD-PAK-01
• Device Lot Number: H0855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RA2025-4068245
• Patient Sequence Number: 1
• Patient Sex: Unknown