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

Model Number M3536A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

It was reported to philips that when the user selects the 12 lead command, the device will return to the main screen.The customer is requesting that the device be returned for bench repair.There was no reported patient involvement/adverse patient impact.

Manufacturer Narrative

One processor pca was returned for failure analysis.The reported problem was duplicated in the lab.The device failed 12-leads ecg tests and was unable to analyze 12-leads ecg data after data acquisition.The available information is consistent with a malfunction of the processor pca.The cause was watchdog software-related.The available information from this report does not support that this malfunction represents a systemic, design, or labeling problem.No further investigation or action is warranted.

Event Description

It was reported to philips that when the user selects the 12 lead command, the device will return to the main screen.There was no reported patient involvement/adverse patient impact.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6236297
• MDR Text Key: 64712622
• Report Number: 1218950-2017-00230
• Device Sequence Number: 1
• Product Code: MKJ
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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