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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART FRX AED

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PHILIPS MEDICAL SYSTEMS HEARTSTART FRX AED Back to Search Results
Model Number 861304
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It has been reported that the device is failing self-test.
 
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Brand NameHEARTSTART FRX
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 Key7655174
MDR Text Key113003281
Report Number3030677-2018-01429
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
050004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number861304
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2010
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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