MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problems Display or Visual Feedback Problem (1184); Physical Resistance/Sticking (4012)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported to philips the device soft keys were not functioning properly.The device was reported to be in use, however, no direct adverse event to the patient or user was reported.

Manufacturer Narrative

Report originally submitted with cfn# 1218950; the correct cfn# is 3030677.

Event Description

It was reported to philips the device soft keys were not functioning properly.The device was reported to be in use, however, no direct adverse event to the patient or user was reported.A philips field service engineer (fse) evaluated the device.The reported issue was confirmed and traced to a faulty processor pca.One processor pca was returned for failure analysis.The reported allegation about the "the soft keys were not functioning properly" was not verified or duplicated during lab tests.The processor pca passed all tests during opcheck and performed as expected.Therefore, there is no fault found with this processor pca.The fse replaced the processor pca.The device passed all performance assurance tests and was placed back into use with the customer.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell-everett highway; bothell WA 98021
• MDR Report Key: 10813727
• MDR Text Key: 216944574
• Report Number: 1218950-2020-06772
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: (01)00884838006652
• Combination Product (y/n): N
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1