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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 Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported to philips that there was a malfunction of therapy receptacle. 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 NameEFFICIA DFM100 DEFIBRILLATOR/MONITOR
Type of DeviceXL+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 Key12717507
MDR Text Key279299923
Report Number9610816-2021-10459
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number866199
Device Catalogue Number866199
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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