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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 Overheating of Device (1437)
Patient Problems Burn, Thermal (2530); Lead(s), Burn(s) From (3161)
Event Type  Death  
Event Description
The user is reporting that during a patient use event, the patient was burned by the electrode when the device was in the process of shocking. The patient outcome is unknown.
 
Event Description
The user is reporting that during a patient use event, the patient was burned by the electrode when the device was in the process of shocking. The patient outcome is unknown. Received new information stating the patient did not survive, however the customer indicates the patient's death is unrelated to the device issue.
 
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Brand NameHEARTSTREAM FR2
Type of DeviceAED
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
bothell WA 98021 8431
Manufacturer (Section G)
PHILIPS HEALTHCARE - BOTHELL
22100 bothell-everett hwy
bldg a
bothell WA 98021
Manufacturer Contact
dana tackett
22100 bothell everett hwy
bothell, WA 98021-8431
8887445477
MDR Report Key7210974
MDR Text Key97964545
Report Number3030677-2018-00156
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 consumer,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2018
Is this an Adverse Event Report? Yes
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 Received01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/22/2018 Patient Sequence Number: 1
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