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

Model Number M3535A

Device Problem Failure to Calibrate (2440)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported the device etco2 calibration failed.There was no patient involvement.

Manufacturer Narrative

This report is based on information provided by a philips service delivery manager and has been reviewed by the philips complaint handling team.The device displayed a 'calibration overdue' message, but the calibration attempt failed.The authorized service personnel (asp) assessed the equipment, and it is currently non-operational.No troubleshooting was performed since we confirmed that the device failed testing.To resolve this issue, we require spare parts that are unavailable due to the heartstart mrx having reached its end of service (eos) status, making repairs impossible due to the lack of available components.Consequently, we informed the customer that we are unable to proceed with repairs, and service can no longer be provided for this unit.Since troubleshooting was not conducted on the device, the cause of the reported issue could not be established.As a result, the reported problem was not confirmed.The customer was informed about the end of life terms, and the device still resides at the customer's site.It has been determined that no further action is necessary at this point.H3 other text : authorized service personnel assessed the equipment.

• 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: 18414624
• MDR Text Key: 331607154
• Report Number: 3030677-2023-05118
• 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

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?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 01/31/2024
• 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