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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTREAM FR2 AED

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PHILIPS MEDICAL SYSTEMS HEARTSTREAM FR2 AED Back to Search Results
Model Number M3841A
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Type  malfunction  
Event Description
The user is reporting the device delivered a shock to the patient when it should not have. The patient outcome is unknown.
 
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Brand NameHEARTSTREAM FR2
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 Key11179809
MDR Text Key228214047
Report Number3030677-2021-00081
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
003565
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberM3841A
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 Received01/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2008
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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