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

Model Number	HEARTSTART ADULT SMART PADS CARTRIDGE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/14/2022
Type of Reportable Event	Death
Event or Problem Description
During a patient use event, it was determined that the pads adhesive may not meet the contact surface area specifications.The patient did not survive.
Event or Problem Description
During a patient use event, it was determined that the pads adhesive may not meet the contact surface area specifications.The patient did not survive.
Additional Manufacturer Narrative
Updated conclusion code.
Additional Manufacturer Narrative
Updated investigation coding based on subsequent review of the case.
Event or Problem Description
During a patient use event, it was determined that the pads adhesive may not meet the contact surface area specifications.The patient did not survive.

• 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: 15152993
• Report Number: 3030677-2022-03792
• Device Sequence Number: 14853410
• Product Code: MKJ
• UDI-Device Identifier: 00884838023741
• UDI-Public: 00884838023741
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,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 Expiration Date: 09/24/2022
• Device Model Number: HEARTSTART ADULT SMART PADS CARTRIDGE
• Device Catalogue Number: M5071A
• Device Lot Number: Y032420-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 03/03/2023; 03/03/2023
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 03/07/2023; 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0881-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male