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

Model Number	M3713A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported that the pads stuck to the liner when attempting to be used for a patient use event.The user was able to replace the pads with a spare set.There are no known consequences or health impact to the patient.

• Brand Name: HEARTSTART
• Common Device Name: 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: dana tackett ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15620801
• Report Number: 3030677-2022-04652
• Device Sequence Number: 6498755
• Product Code: MKJ
• UDI-Device Identifier: 00884838002845
• UDI-Public: 00884838002845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: M3713A
• Device Catalogue Number: M3713A
• Device Lot Number: 030322-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown