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

Model Number M3535A

Device Problems Computer Software Problem (1112); Electrical /Electronic Property Problem (1198)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

It was reported that calibration was requested and, when the options were activated, a fault occurred.There was no patient involvement.

Manufacturer Narrative

This report is based on information provided by quote administrator (qa) and customer care solution center has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart mrx defibrillator/monitor indicating that the device has a faulty configuration option and is unable to be activated.The customer evaluated the device and received remote support from the customer care solution center, during which onsite diagnostic service was offered to the customer.Based on the information available there is insufficient information to confirm the reported problem.We are unable to confirm the final disposition of the device because the quote expired and the customer did not respond to requests for additional information to obtain the device evaluation, repair, and operational status.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : the customer received remote support.

• 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: 18509504
• MDR Text Key: 333109961
• Report Number: 3030677-2024-00178
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/03/2024
• Initial Date FDA Received: 01/13/2024
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 02/11/2024
• 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