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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 Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
Event Type  Injury  
Event Description
It was reported to philips that the power cable was sparked.User' arm was numb when the device was powered on and power line cable was sparked.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
A follow up report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that the power cable was sparked.User' arm was numb when the device was powered on and power line cable was sparked.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
Complaint evaluation: the customer requested that a philips field service engineer (fse) be dispatched to the customer site.The reported issue was confirmed and traced to the customer did not use original power cable.Customer resolution and conclusion: the power cable was replaced and the malfunctioning part was not a philips product.The device successfully passed all required tests.The device remains at the customer site and no further evaluation is required at this time.
 
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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 Key13627649
MDR Text Key286332598
Report Number3030677-2022-01277
Device Sequence Number1
Product Code MKJ
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,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number866199
Device Catalogue Number866199
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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