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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART FRX DEFIB, US ENGLISH AED

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PHILIPS NORTH AMERICA LLC HEARTSTART FRX DEFIB, US ENGLISH AED Back to Search Results
Model Number 861304
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Cardiac Arrest (1762)
Event Date 09/22/2021
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
The user reported that during a patient use event, the device successfully delivered two shocks but on the third attempt, the device indicated the shock was not successful despite the shock appearing to have been delivered. The device requested the pads be replaced. A second device was retrieved to assist in this patient use case. The patient did not survive.
 
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Brand NameHEARTSTART FRX DEFIB, US ENGLISH
Type of DeviceAED
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
dana tackett
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key12528766
MDR Text Key273217926
Report Number3030677-2021-14500
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number861304
Device Catalogue Number989803138201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/24/2021 Patient Sequence Number: 1
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