MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART HOME DEFIBRILLATOR, HS1; AED

Model Number M5066A

Device Problem Output Problem (3005)

Patient Problem Cardiac Arrest (1762)

Event Date 03/12/2024

Event Type  Death  

Event Description

It has been reported that the device did not activate as expected when retrieved for a patient use event.The patient did not survive.

• Brand Name: HEARTSTART HOME DEFIBRILLATOR, HS1
• 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: 18973781
• MDR Text Key: 338524909
• Report Number: 3030677-2024-01107
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838075849
• UDI-Public: 00884838075849
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M5066A
• Device Catalogue Number: 453564994311
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death