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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20E
Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer's device and duplicated the reported issue.Physio found the therapy pcb to contain soot residue, and the j2 connector to the energy capacitor broken and sooty.Physio replaced the device's therapy pcb and energy capacitor to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
 
Event Description
The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed an "abnormal energy" message and the device did not deliver energy.
 
Manufacturer Narrative
Physio-control further evaluated the removed therapy pcb assembly and determined that the cause of the reported issue was due to shorted diode, cr44.
 
Event Description
The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed an "abnormal energy" message and the device did not deliver energy.
 
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Brand Name
LIFEPAK 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 Key11591373
MDR Text Key243766375
Report Number0003015876-2021-00666
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873813768
UDI-Public00883873813768
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20E
Device Catalogue Number99507-000002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Date Manufacturer Received06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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