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

Model Number M5066A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Cardiac Arrest (1762)

Event Date 04/15/2024

Event Type  Death  

Event Description

It has been reported that the aed did not shock.The customer stated that the aed said to "step back" and it did not shock.The patient did not survive.

• Brand Name: HEARTSTART
• 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: 19153062
• MDR Text Key: 340717759
• Report Number: 3030677-2024-01468
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838075849
• UDI-Public: 00884838075849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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
• Device Operator: Health Professional
• Device Model Number: M5066A
• Device Catalogue Number: 453564994311
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death