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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FR3, REFURB TEXT AED, LANGUAGE CONFIGURA

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PHILIPS MEDICAL SYSTEMS FR3, REFURB TEXT AED, LANGUAGE CONFIGURA Back to Search Results
Model Number 861388
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 and the device may not be passing self tests.
 
Manufacturer Narrative
This issue was previously reported on (b)(4) with mdr 3030677-2020-01501. The device investigation is pending.
 
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Brand NameFR3, REFURB TEXT AED, LANGUAGE CONFIGURA
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 Key10659365
MDR Text Key211517464
Report Number3030677-2020-01654
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K111693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2020
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 Other
Device Model Number861388
Device Catalogue Number861388
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2012
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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