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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NORTH AMERICA HEARTSTREAM XL; AED
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PHILIPS MEDICAL SYSTEMS NORTH AMERICA HEARTSTREAM XL; AED Back to Search Results
Model Number HEARTSTREAM XL
Device Problems Break (1069); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 01/04/2016
Event Type  malfunction  
Event Description
A (b)(6) black female presented to the physician's office for a complaint of sore throat.She collapsed in the waiting room while waiting to be seen.The pt was pulseless with no spontaneous respirations.Cpr was started immediately and 911 was call.Aed pads were applied to the pt and plugged into the machine.The aed was not functioning properly because the machine kept repeating "apply pads".A staff member checked the connection and then turned the machine off and then back on.Finally, the aed started "analyzing" and then "no shock advised".The aed machine did not analyze after the initial evaluation, and it did not give any further instructions.It just displayed either "monitoring" or "pausing" on the monitor.No pulse was palpated, so cpr was continued until the rescue squad arrived.
 
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Brand Name
HEARTSTREAM XL
Type of Device
AED
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NORTH AMERICA
bothell WA 98041
MDR Report Key5380722
MDR Text Key36500028
Report NumberMW5059418
Device Sequence Number1
Product Code LDD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHEARTSTREAM XL
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age52 YR
Patient Weight113
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