MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; XL+ DEFIBRILLATOR

Model Number 861290

Device Problem Failure to Discharge (1169)

Patient Problems Death (1802); Hypothermia (1915)

Event Date 02/17/2018

Event Type  Death  

Manufacturer Narrative

Patient information has been requested, but not yet received.The customer requested that a philips field service engineer (fse) be dispatched to the customer site.The fse made several tests on the equipment and also tested with a tester fluke.The fse team was sent onsite to the test he device in the clinical setting.As a witness, the director, the engineering, and other personal were present to testified that the equipment was in optimum condition.It was working fine.The fse reviewed the status logs.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.Philips cannot rule out a malfunction of the device at the time it was reported.There is no indication of a systemic problem; no further investigation or action is warranted.

Event Description

It was reported to philips that the device ".Delivered a first discharge but it doesn't work a second and third discharge and the patient died".The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.The patient involved died.The clinicians tried to use another device.The second device did not discharge as well.The images of the printed case event summary with rhythm strips show multiple examples of dotted lines which indicate that no ecg leads or pads leads were connected to the patient.The patient arrived in the emergency department without vital signs and hypothermic.The physician stated that the patient arrived dead.No other patient information is available due to patient privacy protection clinical policy.The engineer reported that the device was in good condition and the patient death was not attributed to the device.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: XL+ DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: richa shah ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7354813
• MDR Text Key: 102950581
• Report Number: 1218950-2018-02701
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K110825
• 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
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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