MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART FR3; AED

Model Number 861388

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Tachycardia (2095)

Event Date 10/10/2023

Event Type  Injury  

Event Description

It has been reported that the device did not shock during a use event.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because live-saving therapy/treatment may have been interrupted/delayed.

• Brand Name: HEARTSTART FR3
• Type of Device: AED
• 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: 17999745
• MDR Text Key: 326446771
• Report Number: 3030677-2023-04236
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838049987
• UDI-Public: 00884838049987
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P160028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• 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?: No
• Device Operator: Health Professional
• Device Model Number: 861388
• Device Catalogue Number: 861388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 12/15/2023; 02/15/2024
• Supplement Dates FDA Received: 12/18/2023; 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening