MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problem Device Alarm System (1012)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

This report is based on information provided by a philips china call center representative and philips field service engineer and has been investigated by the philips complaint handling team.Philips received a complaint on the m3536a (heartstart mrx als monitor) indicating that the device alarmed and issued an error message of "n/a." the event was outside of use and there was no reported patient nor user harm.Visual inspection found the equipment alarm.The following functional tests were performed: operational test; functional test; self-test.Results of functional testing indicate the device alarmed, issued an error message of "n/a" and failed to pass the self-test.The device was evaluated onsite, the ecg lead was found to be disconnected from the device.It was determined the failure falls under the scope of fco86100193.The ecg lead was reconnected to the device and operational self-test was re-performed.The device was returned to service.The device is not available for further investigation as it remains at the customer site.Based on the information available and the testing conducted, the cause of the reported problem was the ecg lead was not connected to the device.The reported problem was confirmed.Based on the information available and results of additional analysis further action has been initiated.The issue was determined to be within the scope of existing fco86100193.Fco86100193 was implemented to resolve the issue.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 device was operational after the ecg lead was connected to the device.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• 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: allison prater ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16663859
• MDR Text Key: 312555742
• Report Number: 3030677-2023-01373
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• 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

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: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/03/2023
• 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