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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20E
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was unable to reproduce the reported issue.The electronic patient records were reviewed and it was observed that impedance level was high that caused the device to display an 'abnormal energy' message.The cause of the high impedance level could not be determined.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
 
Event Description
A customer contacted physio-control to report that their device displayed an 'abnormal energy' message during patient treatment.The customer advised that a backup device was available and used successfully to defibrillate the patient.The patient associated with the event was not harmed.Physio-control contacted the customer in order to obtain additional information about the patient; however no information was available.
 
Event Description
A customer contacted physio-control to report that their device displayed an 'abnormal energy' message during patient treatment.The customer advised that a backup device was available and used successfully to defibrillate the patient.The patient associated with the event was not harmed.Physio-control contacted the customer in order to obtain additional information about the patient; however no information was available.
 
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Brand Name
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key8896392
MDR Text Key189710677
Report Number0003015876-2019-01338
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20E
Device Catalogue Number99507-000028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2019
Date Manufacturer Received02/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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