MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 ADULT SMART PADS CARTRIDGE (M5071A)

Model Number HEARTSTART ADULT SMART PADS CARTRIDGE

Device Problem Material Separation (1562)

Patient Problem Cardiac Arrest (1762)

Event Date 04/20/2023

Event Type  Death  

Event Description

It has been reported that the user noted the gel of the pads was peeled when they were retrieved for a patient use.The patient did not survive.

• Brand Name: HS1 ADULT SMART PADS CARTRIDGE (M5071A)
• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16809928
• MDR Text Key: 313952529
• Report Number: 3030677-2023-01705
• Device Sequence Number: 1
• Product Code: MKJ
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEARTSTART ADULT SMART PADS CARTRIDGE
• Device Catalogue Number: M5071A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: A
• Removal/Correction Number: M5071A Z-0081-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Death