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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 Problems Communication or Transmission Problem (2896); Device Sensing Problem (2917)
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 Key7042991
MDR Text Key92521503
Report Number3030677-2017-02377
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838049123
UDI-Public(01)00884838049123
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
020715
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2017
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 Received11/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2015
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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