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

Model Number M3535A

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

Patient Problems Cardiac Arrest (1762); Death (1802); Loss Of Pulse (2562)

Event Date 01/30/2018

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Patient information requested, not yet received.

Event Description

It was reported to philips that the device analyzed the patient rhythm as shock advised, charged, and delivered a shock while in aed mode when the patient's rhythm was pulseless electrical activity (pea).The patient involved was reported in cardiac arrest, the device was connected to the patient by a special emergency response team of clinicians (crash team), and set in aed mode.While cpr was being performed, the defibrillator in the aed mode analysed the trace as shock advised.The aed subsequently charged and a shock was delivered, but a review of the patient's rhythm showed that the patient was in pea.The event summary shows that a "no shock advised" message was given by the device on two occasions during the incident., but the crash team did not recall hearing these events.The patient did regain consciousness but was then made "dnacpr" and subsequently died a few hours after arrest.

Event Description

It was reported to philips that the device analyzed the patient rhythm as shock advised, charged, and delivered a shock while in aed mode when the patient's rhythm was pulseless electrical activity (pea).The patient involved was reported in cardiac arrest, the device was connected to the patient by a special emergency response team of clinicians (crash team), and set in aed mode.While cpr was being performed, the defibrillator in the aed mode analysed the trace as shock advised.The aed subsequently charged and a shock was delivered, but a review of the patient's rhythm showed that the patient was in pea.The event summary shows that a "no shock advised" message was given by the device on two occasions during the incident., but the crash team did not recall hearing these events.The patient did regain consciousness but was then made "dnacpr" and subsequently died a few hours after arrest.The fse reported that the issue was not confirmed and there was no trouble found with the device.The device passed all performance assurance testing and was placed back in service.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: richa shah ; 22100 bothell-everett hwy; bldg a; bothell, WA 98021 ; 9786871501
• MDR Report Key: 7241750
• MDR Text Key: 99029486
• Report Number: 1218950-2018-01286
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M3535A
• Device Lot Number: .
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2005
• 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