MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILLATOR

Model Number M3535A

Device Problem Image Display Error/Artifact (1304)

Patient Problems Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2023

Event Type  Death  

Manufacturer Narrative

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

The customer reported to philips that the device has the presence of artifacts on the ecg trace, probably due to a fault on the power supply.The device was reported to be in use, however there was no adverse event to the patient or user.

Manufacturer Narrative

This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart mrx indicating that the device did not analyze the ecg tracing and therefore did not discharge.The patient is reported to have died.No further details regarding the procedure or circumstances regarding the death were provided despite multiple attempts.The fse evaluated the device on site.The fse tested the defibrillator and although it worked properly, the customer revealed the printed trace showing a 50hz noise.Therefore, the fse replaced the power pca in order to resolve the reported issue.The device remains at the customer site and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the power pca.The reported problem was confirmed through the printed trace revealed by the customer.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 fse replaced the power pca to resolve the reported issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Additional information provided by the customer states that the patient died.This report has been updated to reflect the patient death.

Event Description

The customer reported to philips that the device has the presence of artifacts on the ecg trace, probably due to a fault on the power supply.Update: the patient expired.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• 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: 17122957
• MDR Text Key: 317118654
• Report Number: 3030677-2023-02354
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K031187
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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