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

Model Number M3535A

Device Problem Mechanical Problem (1384)

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

Event Date 04/03/2024

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 to philips that the motor is not functioning properly.There was no reported patient impact or injury.

Manufacturer Narrative

This report is based on information provided by a philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart mrx defibrillator indicating that the motor was not functioning properly.Multiple good faith efforts were made to obtain additional information associated with this complaint evaluation, but there is no additional information available.The device disposition remains unknown as there were no response in attempts to obtain information.Based on the information available, we were unable to determine the reported problem.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 information in the complaint investigation summary addresses the current investigation findings.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened for reassessment.H3 other text: multiple good faith efforts were made to obtain additional information without a response.

• 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: 19165671
• MDR Text Key: 340956718
• Report Number: 3030677-2024-01486
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 04/03/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2012
• 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