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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 Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported to philips that the device¿s paddle can not be detected.There was no patient involvement.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 GOLDWAY (SHENZHEN) INDUSTRIAL, INC 
no.2 keji north 3rd road
nanshan district
shenzhen 51805 7
CH   518057
Manufacturer Contact
sophia liu
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key10783545
MDR Text Key216319441
Report Number1218950-2020-06666
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838023680
UDI-Public(01)00884838023680
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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