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

Model Number M3536A

Device Problem Pacing Problem (1439)

Patient Problems Cardiopulmonary Arrest (1765); Low Oxygen Saturation (2477)

Event Date 09/17/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips the device was unable to obtain pacing capture during a patient event.The involved patient was stated to have desaturated after the first failed attempt.During the same event, the customer tried a second time to obtain pacing and when unable to do so, the patient went asystolic.A non-philips device was then used to deliver pacing and the patient stabilized.

Manufacturer Narrative

The device was evaluated by a philips representative.The device passed all required testing and was returned to the customer site.Event strips and/or an electronic event file were not available for review.Philips is unable to verify the reported malfunction.Patient information was requested, the customer did not provide.

• 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 ; 9723897516
• MDR Report Key: 6029501
• MDR Text Key: 57419680
• Report Number: 1218950-2016-06502
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• 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: 10/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2007
• 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): Other