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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ELECTRONICS NORTH AMERICA CORPORATION HEARTSTART XL; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHILIPS ELECTRONICS NORTH AMERICA CORPORATION HEARTSTART XL; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number M4742A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/29/2020
Event Type  malfunction  
Event Description
Cardiac surgeon used the internal defib paddles during our case to get our patient back into a perfusing rhythm.Paddles were put away.Patient was bleeding and we used suction in the pericardium.While sucking out the pericardium, the cardiac surgeon pulled out from behind the heart what looked like a piece of sharp plastic.After further investigation, we matched that sharp piece to part of our internal defib paddles.Piece handed off the field, a "repair" tag was placed on the paddles and taken out of service.
 
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Brand Name
HEARTSTART XL
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
3000 minuteman rd.
andover MA 01810
MDR Report Key9859735
MDR Text Key184277909
Report Number9859735
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/04/2020,02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM4742A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2020
Device Age9 YR
Event Location Hospital
Date Report to Manufacturer03/20/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age25915 DA
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