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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. LIFEPAK 15 CARDIAC MONITOR DEFIB

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PHYSIO-CONTROL, INC. LIFEPAK 15 CARDIAC MONITOR DEFIB Back to Search Results
Model Number LP-15
Device Problem No Display/Image (1183)
Patient Problem Loss of consciousness (2418)
Event Date 08/03/2016
Event Type  malfunction  
Event Description
Lifepak 15 cardiac monitor defibrillator failed to display a cardiac rhythm on the screen utilizing limb leads or with the combidefib pads during a cardiac arrest. Despite troubleshooting and ensuring all cords were attached and that there was no known issue as to why there was no display of the rhythm. Reported to physio control, open case # (b)(4). The decision was made to recycle the monitor to see if it would correct the problem. After recycling the device, it came back on to display a cardiac rhythm. The problem occurred again about ten minutes later. Recycling the device once again returned a rhythm to the screen. High quality cpr was initiated and continued without delay during the incident. Initial defibrillation may have been delayed by as much as two minutes as the pt went unresponsive and was being ventilated with chest compressive for that approximate duration until the monitor came back on with a rhythm displayed as ventricular fibrillation and the pt was immediately defibrillated.
 
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Type of DeviceLIFEPAK 15 CARDIAC MONITOR DEFIB
Manufacturer (Section D)
PHYSIO-CONTROL, INC.
MDR Report Key5939139
MDR Text Key54460869
Report NumberMW5064636
Device Sequence Number1
Product Code MKJ
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 09/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLP-15
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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