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

Model Number 861290

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Atrial Fibrillation (1729); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

Patient outcome code grid = death.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported the device showed heart rate as 0 and ecg rhythm was captured while alarming asystole.The patient died.Additional details have been requested.

Event Description

It was reported the device showed heart rate as 0 and ecg rhythm was captured while alarming asystole.It was initially reported the patient had died.Based on additional clinical information provided by the customer, it has been confirmed that the patient did not experience a serious injury or harm because of the alleged malfunction.This report has been updated from death to product problem.

Manufacturer Narrative

A clinical harm review was performed and information indicated that the patient outcome was not death.Initial clinical details indicate the patient was undergoing planned surgery and placed under general anesthesia, catheters accessed the heart via right femoral vein.Radiofrequency ablation of the pulmonary veins was performed with 3d mapping.3-4 dcrs performed during the procedure with pads in al location (200j, sync, rhythm via pads).Dcr unsuccessfully reverted patient into sr, no acute reversion of atrial fibrillation (af).Post procedure, pads changed to ap location with manual pressure, 200j dcr briefly reverted patient to sinus rythm with af recurring shortly afterwards.Additional details indicate the device was showing a clear ecg trace (showing afib) but was incorrectly alarming "asystole".There were no adverse outcomes from the unsuccessful cardioversions.The patient's health did not deteriorate during the procedure.Customer continued the procedure as per normal after the unsuccessful dcrs with the patient in af.The patient was discharged the next day and was still in af.Given this information, this event does not meet the criteria for a serious injury.Available details indicate that the device had exhibited symptoms of a critical failure and the customer was advised to remove the device from service.The device was not available for additional investigation.Because the device is out of warranty, cannot be repaired, and was returned to biomed, the cause of the reported problem is unknown and cannot be confirmed.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.The customer was advised their device was out of warranty and cannot be repaired.The customer was advised to remove the device from service.The customer was advised they can purchase a replacement through philips sales / their philips distributor.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : device is end of life.

• 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: 17270040
• MDR Text Key: 318487703
• Report Number: 3030677-2023-02681
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 150 KG