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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART ONSITE AED

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PHILIPS MEDICAL SYSTEMS HEARTSTART ONSITE AED Back to Search Results
Model Number M5066A
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It has been reported that the device is not recognizing multiple sets of pads.
 
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Brand NameHEARTSTART ONSITE
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 Key7259672
MDR Text Key99608469
Report Number3030677-2018-00321
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838049123
UDI-Public(01)00884838049123
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
020715
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberM5066A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
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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