MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS PEDI RADIOTRANSPARENT PADS; DEFIBRILLATOR PADS

Model Number	M3719A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The pads connector project changed the als pads connector assembly supplier (tier 2) for part number m3719a.As part of the project, the hazardous substance compliance evidence was updated.On (b)(6) 2023, it was discovered that the new supplier's wiring insulation of the connector assemblies used to manufacture m3718a and m3719a pads wiring insulation contains a pvc compound material comprised of 20-30% dehp material.This material has been used since initial production release.This level of dehp material does not comply with the following regulations: rohs2; rohs3; proposition 65; reach.Phthalates have been in the m3719a wire insulation material since initial production release.There was no patient involvement.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.
Additional Manufacturer Narrative
The pads connector project, lc1195-011 [ref-02], changed the pads connector assembly supplier from dickten masch to new deantronics for part numbers m3718a and m3719a.As part of the project, the hazardous substance compliance evidence was updated on 17-jan-2023, philips was notified that the wiring insulation of the dickten masch connector assemblies used to manufacture m3718a and m3719a pads contain a pvc compound material comprised of 20-30% dehp material.This material has been used since initial production release.This level of dehp material does not comply with the regulations.Based on the information available and the testing conducted, the cause of the reported problem was identified as inadequate process.The reported problem was confirmed.Based on the information available and results of additional analysis, further action has been initiated.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.Analysis was performed and investigation has been completed.All pads in the field have expired.Per dickten masch, the last shipment of m3718/m3719a pads was released in may 2021 and expired 04-apr-2023.If additional information is received the complaint file will be reopened.

• Brand Name: HS PEDI RADIOTRANSPARENT PADS
• Common Device Name: DEFIBRILLATOR PADS
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: jacqueline nishino ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16507793
• Report Number: 3030677-2023-01015
• Device Sequence Number: 6919258
• Product Code: MKJ
• UDI-Device Identifier: 00884838002883
• UDI-Public: 00884838002883
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup

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: Other
• Device Model Number: M3719A
• Device Catalogue Number: M3719A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 07/19/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown