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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; XL+ DEFIBRILLATOR Back to Search Results
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.
 
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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 Key7642836
MDR Text Key112498144
Report Number1218950-2018-05276
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K110825
Number of Events Reported1
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 Number861290
Device Catalogue Number861290
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 Received06/27/2018
Supplement Dates Manufacturer Received06/22/2018
Supplement Dates FDA Received10/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age94 YR
Patient Weight60
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