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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. EFFICIA DFM100; XL+DEFIBRILLATOR
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PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. EFFICIA DFM100; XL+DEFIBRILLATOR Back to Search Results
Model Number 866199
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2023
Event Type  malfunction  
Event Description
This report is based on information provided by philips bench technician and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator indicating that the measurement module was defective.Further details regarding the allegation were requested; however, no further information was provided.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.
 
Manufacturer Narrative
(b)(6).
 
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Brand Name
EFFICIA DFM100
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 Key18416579
MDR Text Key331594332
Report Number3030677-2023-05108
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 Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2023
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
Date Manufacturer Received11/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2020
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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