MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART ADULT/CHILD PLUS PADS; DEFIBRILLATOR PADS

Model Number	M3713A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event, and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported to philips that the heartstart adult/child plus pads (m3713a) and lot no.072825-01 exhibited abnormal and uneven adhesion on one pad.There was no patient involvement reported.
Additional Manufacturer Narrative
The parent record has been identified as a duplicate of (b)(4), reported under mdr number 3030677-2026-100018.This case will be closed due to duplication.Please refer to (b)(4) for the complete investigation.

• Brand Name: HEARTSTART ADULT/CHILD PLUS PADS
• Common Device Name: DEFIBRILLATOR PADS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: tanya deschmidt ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 24007014
• Report Number: 3030677-2026-100019
• Device Sequence Number: 9343592
• Product Code: MKJ
• UDI-Device Identifier: 00884838111325
• UDI-Public: (01)00884838111325(17)270630(10)072825-01
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K002806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: Health Professional
• Device Model Number: M3713A
• Device Catalogue Number: M3713A
• Device Lot Number: 072825-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/23/2026
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown