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

Model Number M3535A

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431)

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

Event Date 11/28/2023

Event Type  malfunction  

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

It was reported the device could not discharge.No patient involvement reported at this time.

Event Description

This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart mrx defibrillator indicating that device cannot discharge.Based on the information available, the cause of reported issue could not be confirmed.Philips engineer instructed customer, redo self-check which fixed the issue.No further evaluation is required.Device is working fine as per manufacturer's specifications after replacement of defective assy capacitor.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Updated summary and code grids.

• 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: 18382783
• MDR Text Key: 331196158
• Report Number: 3030677-2023-05072
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• 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?: No
• 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?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 02/22/2024
• 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