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

Model Number M3535A

Device Problems Detachment Of Device Component (1104); Failure to Sense (1559)

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 the device sync function disengaged and lost the r wave marking indicator while remaining fully charged with qcpr puck movement during a demonstration video for synchronized cardioversion in a lab setting.This is a safety concern if the user fails to recognize that the sync function has been lost and presses the shock button because there is a risk of the shock being delivered on the t wave causing life threatening ventricular the incident was observed during the filming of demonstration video using simulation equipment.There was no reported patient involvement/adverse patient impact.

Event Description

It was reported to philips, that during the filming of a demonstration video, the device sync function disengaged and lost the r wave marking indicator while remaining fully charged with qcpr puck movement.This is a safety concern if the user fails to recognize that the sync function has been lost and presses the shock button because there is a risk of the shock being delivered on the t wave causing life threatening ventricular tachycardia and/or ventricular fibrillation.There was no reported patient involvement.

Manufacturer Narrative

Philips determined that the heartstart mrx was behaving the way it was designed.Shaking the q-cpr meter as shown in the (b)(6) video is not the same as dropping or kicking the bag carrying the meter, or having the crash cart drawer slammed or someone bumping into it.Shaking the q-cpr meter simulates the repetitive motion of chest compressions.Having the defibrillator unsync is a safer situation than having the sync function remain enabled and potentially unrecognized when a defibrillation is needed.When the sync function is enabled, a shock will only be delivered when the defibrillator senses an r-wave in the ecg.If a stable patient in need of synchronized cardioversion becomes unstable (goes into ventricular fibrillation), and a shock is attempted while sync is active, the shock will not be delivered.This could result in a delay of therapy while the situation is identified and the sync is disabled.Further, while this situation is being identified, the clinicians would check for both the energy selected and the sync status.Even if the sync status was disabled and the shock was delivered at a lower energy which failed to convert the rhythm, the clinicians would continue chest compressions and follow other appropriate resuscitation protocols, including checking the energy setting of the defibrillator prior to attempting to deliver another shock.The american heart association advanced cardiac life support guidelines recommend that if delays occur with synchronized shocks, immediately switching to unsynchronized shocks.The heartstart mrx behavior facilitates this rather than contributing to a delay in treatment.The feature on the heartstart mrx to automatically deactivate the sync function when the motion caused by chest compressions is sensed by the q-cpr meter is intended to allow the delivery of a shock to a patient who has gone from stable to an unstable condition, thus preventing a delay in shock delivery.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; bldg a; andover, MA 01810 ; 9786871501
• MDR Report Key: 7384921
• MDR Text Key: 104044813
• Report Number: 1218950-2018-03024
• 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: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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