MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR

Model Number M3535A

Device Problems Failure to Deliver Shock/Stimulation (1133); No Display/Image (1183)

Patient Problem Cardiopulmonary Arrest (1765)

Event Type  Injury  

Event Description

It was reported to philips that the heartstart mrx monitor / defibrillator failed during a code on the midnight shift.Philips is considering this event to be a serious injury as the event occurred while the device was in use on a patient in cardiac arrest.While admitted on (b)(6) 2019 during the midnight shift, the patient experienced an event of cardiopulmonary arrest, the heartstart mrx device was connected to the patient via defibrillator pads, and cardiopulmonary resuscitation (cpr) efforts were initiated.It was reported that during the ¿code¿, the display ¿was going blank and nothing was showing up¿ when the defibrillator pads were connected to the patient.The defibrillator pads brand, model, and expiration date was not reported.It is unknown if any shocks were attempted or administered during the event.The outcome of the patient experiencing a cardiopulmonary arrest was not reported.A ¿lead off¿ message and a dashed line appear on the display if an electrode or lead becomes disconnected.A dashed line appears on the display if a pad becomes disconnected (heartstart mrx instructions for use m3535a/m3536a, publication number 453564307761, edition 2, 2012, page 330).

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: laura scanlan ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8932516
• MDR Text Key: 155624861
• Report Number: 1218950-2019-06429
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2009
• 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