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, this report is being considered a serious injury.The second pad is addressed 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 pr (b)(4).It was initially reported that there may have been a delay in life saving therapy, however, it was later clarified by email from technical support that the customer was monitoring a patient at the time of the issue.Therefore, this report has been updated from a serious injury to a product problem.The second pad is addressed in pr (b)(4).The customer contacted the philips response center.The customer shipped the involved pad set to philips for evaluation.One defibrillation pad set was returned for failure analysis.The reported problem was verified.The sternum pads presented significant un-uniform gel surface and the apex pads showed signs of air/bubbles between the gel and the clear plastic liner resulting in pads failing tests.The reported problem was verified.The pad set will be 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: 12871559
• Report Number: 3030677-2021-15928
• Device Sequence Number: 20270991
• 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?: Yes
• 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: 12/21/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/20/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown