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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 M3860A
Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Date 02/25/2017
Event Type  Death  
Event Description
During a patient use event, the user is questioning the "no shock advised" notification given by the device.The patient did not survive.
 
Manufacturer Narrative
Test conducted at the customer site after event confirmed the device is operating to its specifications.User refused to return device for evaluation.
 
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Brand Name
HEARTSTREAM FR2
Type of Device
AED
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 Key6373485
MDR Text Key68849348
Report Number3030677-2017-00495
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
003565
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3860A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age66 YR
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