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

Model Number M3536A

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/02/2016

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

The customer contacted philips to report an observation made during a resuscitation effort where the qcpr meter was used.Approximately 15 minutes after a resuscitation effort was initiated (and 6-7 minutes after intubation) the users observed blood coming through the ventilator tube.The users described this as an "arterial bleed" and wonder whether the use of the qcpr meter was related to the observed internal bleeding.We are considering this as a serious injury.We have requested additional information about this event and are awaiting a response.

Manufacturer Narrative

The qcpr event summary was evaluated and showed adequate rate and depth of compressions.There was no report of failed operational check for either the device or qcpr meter.This event was initially reported as a serious injury based on the information provided, that blood was noted in the ventilator tube during a resuscitation effort.Philips received additional information that the involved patient died.There was no allegation that the observed blood in the tube impacted the patient outcome.There was no allegation that the device failed to deliver therapy.Seven shocks were delivered to the patient.Qcpr is an optional functionality that provides feedback to the user regarding chest compressions and ventilation.The heartstart mrx instructions for use warns the user about possibly rib fracture and other chest injuries."warning: properly performed cpr can result in the fracturing of a patient's ribs or other chest injuries, including external chest wall bruising or abrasion.If patient rib or chest integrity has been compromised, continue to provide cpr in accordance with your local protocol." the device remains at the customer site.There was no information that supports that a malfunction occurred.

Manufacturer Narrative

The become aware date has been updated to 8/15/2016.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5765521
• MDR Text Key: 48664458
• Report Number: 1218950-2016-03942
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2008
• 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
• Patient Outcome(s): Death; Other
• Patient Age: 75 YR
• Patient Weight: 70