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

Model Number HEARTSTART ADULT SMART PADS CARTRIDGE

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2022

Event Type  malfunction  

Event Description

It was determined that the pads adhesive may not meet the contact surface area specifications.

• Brand Name: HEARTSTART
• Type of Device: 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: heidi fraley ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15776249
• MDR Text Key: 305335588
• Report Number: 3030677-2022-05083
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023741
• UDI-Public: 00884838023741
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• 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
• Device Operator: Other
• Device Expiration Date: 02/06/2024
• Device Model Number: HEARTSTART ADULT SMART PADS CARTRIDGE
• Device Catalogue Number: M5071A
• Device Lot Number: Y080621-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1