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U.S. Department of Health and Human Services

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

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PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC HEARTSTART XL+DEFIBRILLATOR/MONITOR Back to Search Results
Model Number 866199
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that defi does not make any sound, error audio. There was no patient involvement. It was reported to philips that xxxxxxx. 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 NameHEARTSTART XL+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 Key12105185
MDR Text Key259591888
Report Number3030677-2021-12649
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeGM
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 Received07/01/2021
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?
Distributor Facility Aware Date06/29/2021
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/29/2018
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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