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

Model Number M3536A

Device Problems Failure to Sense (1559); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Event Description

While performing onsite service for the device, an authorized field service engineer noted that the device was not able to recognize that a therapy cable had been attached.There was no reported patient involvement or adverse patient/user impact as a result of the alleged failure.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: michael fijalkiewicz ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8440357
• MDR Text Key: 139537241
• Report Number: 1218950-2019-02191
• Device Sequence Number: 0
• Product Code: MKJ
• 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
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2010
• 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