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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2020
Event Type  malfunction  
Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
The customer contacted physio-control to report that their device powered off by itself during a patient event.The crew was able to manually power the device back on.This issue is patient related; however there was no adverse patient outcome reported.The customer advised that there were no adverse effects to the patient as a result of the reported issue.Later back at the station while performing test shocks, the customer observed the device displayed an energy fault message.
 
Event Description
The customer contacted physio-control to report that their device powered off by itself during a patient event.The crew was able to manually power the device back on.This issue is patient related; however there was no adverse patient outcome reported.The customer advised that there were no adverse effects to the patient as a result of the reported issue.Later back at the station while performing test shocks, the customer observed the device displayed an energy fault message.
 
Manufacturer Narrative
Physio-control evaluated the customer¿s device but was unable to duplicate the reported issue.Physio downloaded the electronic records from the customer¿s device and was able to confirm that their device experienced an inappropriate loss of power.Physio replaced the power pcb assembly, the battery wire harness assembly and the battery pins, then completed other unrelated repairs.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio-control determined that the cause of the reported issue was fretting corrosion on the battery wire harness contacts of connector j11 and the mating power pcb assembly contacts of connector p11 and worn battery pins.The fretting corrosion on j11/p11 and worn battery pins, can all increase the resistance of the input power path.This increase in resistance can result in a sudden loss of device power under conditions of high current usage from functions such as printing a code-summary® record.The excessive voltage drop at the contacts triggers the power fail detector circuit on the power board, which causes the device to power cycle.
 
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Brand Name
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key10814334
MDR Text Key215490333
Report Number0003015876-2020-01678
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873912782
UDI-Public00883873912782
Combination Product (y/n)N
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-001218
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Date Manufacturer Received12/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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