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

Model Number 861304

Device Problem Unexpected Shutdown (4019)

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

Event Type  malfunction  

Event Description

It has been reported that during a patient use event, the device turned off by itself after delivering a shock.There was no impact to the patient.

• 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: 19175426
• MDR Text Key: 340960952
• Report Number: 3030677-2024-01496
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838080768
• UDI-Public: 00884838080768
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P180028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861304
• Device Catalogue Number: 861304
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1