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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FR3, REFURB ECG AED - JAPANESE

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PHILIPS MEDICAL SYSTEMS FR3, REFURB ECG AED - JAPANESE Back to Search Results
Model Number 861389
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It has been reported that the device speakers are not functioning properly.
 
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Brand NameFR3, REFURB ECG AED - JAPANESE
Type of DeviceAED
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
bothell WA 98021
Manufacturer Contact
dana tackett
22100 bothell everett hwy
bothell, WA 98021
MDR Report Key10659115
MDR Text Key211518136
Report Number3030677-2020-01648
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number861389
Device Catalogue Number861389
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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