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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC EFFICIA DFM100 DEFIBRILLATOR/MONITOR; XL+ DEFIBRILLATOR

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PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC EFFICIA DFM100 DEFIBRILLATOR/MONITOR; XL+ DEFIBRILLATOR Back to Search Results
Model Number 866199
Device Problem Failure to Discharge (1169)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2022
Event Type  malfunction  
Event Description
It was reported to philips that the device was not discharging.Device was in clinical use at time of event.However, no patient harm reported.There was no adverse event.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 was not discharging.Device was in clinical use at time of event.However, no patient harm reported.There was no adverse event.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
EFFICIA DFM100 DEFIBRILLATOR/MONITOR
Type of Device
XL+ DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC
no.2 keji north 3rd road
nanshan district
shenzhen
CH 
Manufacturer (Section G)
PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC
no.2 keji north 3rd road
nanshan district
shenzhen
CH  
Manufacturer Contact
feng she
no.2 keji north 3rd road
nanshan district
shenzhen 
CH  
7552698099
MDR Report Key13494952
MDR Text Key285389946
Report Number3030677-2022-00794
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodePL
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number866199
Device Catalogue Number866199
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/28/2022
Initial Date FDA Received02/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2017
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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