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

Model Number	M3713A
Medical Device Problem Codes	Material Discolored (1170); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
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 a quality issue.There was no patient involvement reported.
Additional Manufacturer Narrative
This report is based on information provided by local philips personnel and has been investigated by the philips complaint handling team.Philips received a complaint regarding the philips m3713a multifunction adult/child electrode pads plus, indicating that pads with lot no.072825-01, manufactured in 2025, appear to have color variations across pads, abnormal or uneven adhesion, and inconsistent gel conditions.No patient involvement was reported.The affected pads have not been returned to philips for further investigation.However, the customer has provided pictures and a video of the alleged defect.The manufacturer reviewed the pictures and video and confirmed the defect with the pads' liner.Based on the available information and reiew of the images/video, the reported problem was caused by a material failure of the pads' gel liner.The reported problem was confirmed.Based on the available information and the results of additional analysis, further action has been initiated.The customer was provided with replacement pads to resolve the issue.If additional information is received, the complaint file will be reopened.

• Brand Name: HEARTSTART ADULT/CHILD PLUS PADS
• Common Device Name: DEFIBRILLATOR PADS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 2039 concourse drive; st. louis MO 63146
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 2039 concourse drive; st. louis MO 63146
• Manufacturer Contact: tanya deschmidt ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 24620720
• Report Number: 3030677-2026-100312
• Device Sequence Number: 10137729
• 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): 04/30/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown