MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR

Model Number 861290

Device Problem Device Alarm System (1012)

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

Event Date 12/24/2023

Event Type  malfunction  

Event Description

It was reported the device automatically alarms.There was no patient involvement.

Manufacturer Narrative

This report is based on information provided by philips remote solution personnel and with an investigation documented by philips complaint handling.Philips received a complaint on the heartstart xl+ defibrillator indicating that the device automatically alarms.The product malfunction was unable to be confirmed because the customer refused the repair service and no work was performed by philips.A review of the service history for this device shows the problem has not been reported again for this device.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.If additional information is received, the complaint file will be reopened for further investigation.H3 other text: customer refused repair service.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: DEFIBRILLATOR
• 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: 18548862
• MDR Text Key: 333343177
• Report Number: 3030677-2024-00269
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1