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

Model Number M3535A

Device Problems Incorrect Measurement (1383); Pacing Problem (1439); Defibrillation/Stimulation Problem (1573)

Patient Problems Asystole (4442); Insufficient Information (4580)

Event Date 08/09/2023

Event Type  malfunction  

Event Description

It was reported that, when put in monitor mode, device was coming up with paced rhythm during an asystole arrest.The device has been exchanged for another mrx device.There was no patient harm.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.

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.Reporter phone and reporting institution phone: (b)(6).

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 mrx indicating that it produced a paced rhythm during an asystole arrest.Multiple requests for additional information regarding the patient outcome were sent but their outcome remains unknown.¿the device was evaluated on site.There were no repairs on the device.There were no device or patient event logs recorded for review.The customer was directly requested for patient information but no response.The system met the required specifications and was returned to use by the customer.Based on the information available and the testing conducted, the cause of the reported problem was unknown.The reported problem was not confirmed.The device is operational.Philips cannot rule out a malfunction at the time it was reported, but no problem could be reproduced, and no repair was warranted.There is no indication of a systemic problem; no further investigation or action is warranted.If additional information is received the complaint file will be reopened.

Event Description

Philips received a complaint on the mrx indicating that it produced a paced rhythm during an asystole arrest.Multiple requests for additional information regarding the patient outcome were sent but their outcome remains unknown.It was reported when put in monitor mode coming up with paced rhythm during an asystole arrest; there is indication that the device was being used in monitor mode on a patient in asystole.The device was not in use to provide life-saving pacing or defibrillation.There is no report of harm.This report has been updated from serious injury to product problem.This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.The device was evaluated on site.There were no repairs on the device.There were no device or patient event logs recorded for review.The customer was directly requested for patient information but no response.The system met the required specifications and was returned to use by the customer.Based on the information available and the testing conducted, the cause of the reported problem was unknown.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The device is operational.Philips cannot rule out a malfunction at the time it was reported, but no problem could be reproduced, and no repair was warranted.There is no indication of a systemic problem; no further investigation or action is warranted.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Correction: this report has been updated from serious injury to product problem.Device problem fda-c-code has been updated to c63085.Patient outcome code has been updated to insufficient information.Health impact grid has been updated to insufficient information.

• 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: 17600145
• MDR Text Key: 321710473
• Report Number: 3030677-2023-03316
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 08/09/2023; 08/09/2023
• Supplement Dates FDA Received: 11/07/2023; 01/18/2024
• 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
• Patient Outcome(s): Life Threatening