MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART PEDIATRIC RADIOTRANSPARENT PADS; DEFIBRILLATOR

Model Number	M3719A
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that, when the customer tried to use the x-ray transmission type pediatric defibrillation pad m3719a, the gel peeled off from the pad side and remained on the mount.The next m3719a prepared in succession was in the same state.The first pad is being addressed in (b)(4).At this time, we are considering that the pad may have been used to provide therapy to a patient.There may have been a delay in life saving therapy, therefore, so that report is being considered a serious injury.The second pad is addressed here in (b)(4).Additional details have been requested.
Event or Problem Description
It was reported to philips that, when the customer tried to use the x-ray transmission type pediatric defibrillation pad m3719a, the gel peeled off from the pad side and remained on the mount.The next m3719a prepared in succession was in the same state.The first pad is being addressed in (b)(4).The second pad is addressed here in (b)(4).The pads were being used to monitor a patient.The device was in use on a patient and there was no adverse event to patient or user.The infant radiotransparent multifunction electrode pads were returned for failure analysis.The infant radiotransparent multifunction electrode pads were received with significant ununiform gel surface and signs of air/bubbles between the gel and the clear plastic liner.The reported problem was verified in the lab.The sternum pad presented significant ununiform gel surface and the apex pad showed signs of air/bubbles between the gel and the clear plastic liner resulting in pads failing tests.The reported issue was confirmed.The infant radiotransparent multifunction electrode pads were scrapped.

• Brand Name: HEARTSTART PEDIATRIC RADIOTRANSPARENT PADS
• Common Device Name: DEFIBRILLATOR
• 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: bethany glynn ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12885868
• Report Number: 3030677-2021-15961
• Device Sequence Number: 3961853
• Product Code: MKJ
• UDI-Device Identifier: 00884838002883
• UDI-Public: 00884838002883
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• 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: Health Professional
• Device Model Number: M3719A
• Device Catalogue Number: M3719A
• Device Lot Number: LOT 002091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 02/14/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown