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

Model Number M3536A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/06/2020

Event Type  Injury  

Event Description

It was reported to philips the heartstart mrx defibrillator was unable to defibrillate while attempting to resuscitate a patient in cardiac arrest.The monitor alerted ¿unable to deliver shock, check pad placement¿.The paramedic crew performed trouble shooting procedures and attempted again.The ¿unable to deliver shock, check pad placement¿ message appeared again.The patient was placed on another unit¿s monitor and transported to the nearest facility.While enroute, another attempt was made with the same monitor to cardiovert the patient and the ¿unable to deliver shock, check pad placement¿ was noted again.The device was reported to be in use on a patient, causing a delay in therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.A philips clinician reviewed the electronic event file from this event.The device was powered on into manual mode and pads were placed.During this event, the users attempted to deliver shocks 3 times at 200j and once at 100j in the sync mode.All of the shocks were aborted due to a patient impedance outside the range for the delivery of therapy.Of note, there were multiple pads off and on messages consistent with an insufficient pads to patient connection.The customer reported receiving messages directing them to check the pads.The heartstart mrx instructions for use troubleshooting section (publication number 453564307761, page 316) describes two messages that may appear related to pads and impedance: "no shock delivered, replace pads now" and "no shock delivered, press pads firmly".The user is directed to make sure that the pads are applied properly and to replace the pads if needed.A philips field service engineer evaluated the device and was unable to duplicate the issue.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.Based on the device testing and information in the event file, philips determined there was no malfunction of the device.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• 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: 10121445
• MDR Text Key: 194114679
• Report Number: 1218950-2020-03282
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2010
• 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
• Patient Outcome(s): Life Threatening