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

Model Number 861290

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

Patient Problem Bradycardia (1751)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is completed.

Event Description

It was reported to philips that the device display heart rate does not match the acoustic signal heart rate of a patient in complete 3rd degree heart block with an effective heart rate of approximately 25 beats per minute.The patient involved was connected to the device and the patient¿s rhythm was identified as an atrioventricular block of 3rd grade.The device display showed the heart rate of 57-60 beats per minute (bpm) while the acoustic signal was heard at a rate of 25 bpm and corresponded accurately with the patient¿s actual heart rate manually obtained by the physician.The physician stated that she observed the display heart rate counted the p waves in addition to the qrs waves.Additional information has been requested.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.

Event Description

It was reported to philips that the device display heart rate does not match the acoustic signal heart rate of a patient in complete 3rd degree heart block with an effective heart rate of approximately 25 beats per minute.A philips field service engineer (fse) performed an operations check test.The device passed all tests.The fse was unable to reproduce the reported problem.A philips clinician reviewed the patient event file.The patient rhythm strip showed complete heart block with a ventricular rate of 20 to 25 bpm.The t wave size/height was equal to the r wave size/height and was counted as a ventricular ectopic beat, which explains the mismatch between higher heart rate displayed by the monitor and the lower auditory pulse rate heard with the pulse oximeter.The patient involved was connected to the device and the patient¿s rhythm was identified as an atrioventricular block of 3rd grade.The device display showed the heart rate of 57-60 beats per minute (bpm) while the acoustic signal was heard at a rate of 25 bpm and corresponded accurately with the patient¿s actual heart rate manually obtained by the physician.The physician stated that she observed the display heart rate counted the p waves in addition to the qrs waves.Additional information has been requested.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.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: XL+ DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS HEALTHCARE - BOTHELL; 22100 bothell-everett hwy; bldg a; bothell WA 98021
• Manufacturer Contact: stohn nishino ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7642836
• MDR Text Key: 112498144
• Report Number: 1218950-2018-05276
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

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: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 06/22/2018
• Supplement Dates FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2016
• 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): Other; Required Intervention
• Patient Age: 94 YR
• Patient Weight: 60