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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 Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It has been reported that the aed did not pass self diagnostic check.There was no negative patient impact.
 
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported that the aed did not pass self diagnostic check.There was no negative patient impact.
 
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Brand Name
HEARTSTART ONSITE
Type of Device
AED
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
bothell WA 98021 8431
Manufacturer Contact
wendy chadbourne
22100 bothell everett hwy
bothell, WA 98021-8431
MDR Report Key4838300
MDR Text Key5936550
Report Number3030677-2015-01424
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
020715
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor,distributor,foreign
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2015
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
Date Manufacturer Received06/08/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberZ-0642-2013, Z-0643-2013
Patient Sequence Number1
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