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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART ONSITE AED

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PHILIPS NORTH AMERICA LLC HEARTSTART ONSITE AED Back to Search Results
Model Number M5066A
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It has been reported that the device will not power up.
 
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Brand NameHEARTSTART ONSITE
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
bethany glynn
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key13122607
MDR Text Key283096250
Report Number3030677-2021-16750
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P160029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM5066A
Device Catalogue Number453564857481
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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