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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
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.The customer, a biomedical engineer advised that they concluded the defibrillation electrodes were bad.The device or defibrillation electrodes were not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
 
Event Description
The customer contacted physio-control to report that during a patient event their device prompted, "connect electrodes".The customer advised this occurred when attempting to shock a patient during a cardioversion procedure.In this state defibrillation therapy would not be available to a patient if needed.The customer advised that the defibrillation electrodes were replaced and the procedure was completed.There was no adverse patient outcome reported.
 
Manufacturer Narrative
Section h10 of the initial medwatch (mfr report # 0003015876-2021-01298) report indicates: 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.The customer, a biomedical engineer advised that they concluded the defibrillation electrodes were bad.The device or defibrillation electrodes were not returned to physio-control for evaluation.The root cause of the reported issue could not be determined.Section h10 of the initial medwatch (mfr report # 0003015876-2021-01298) report should indicate: 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.The device was not returned for evaluation.The customer changed the electrodes and confirmed normal function.The root cause was determined to be the electrodes (lot #033933).The electrodes were not returned to physio-control for further review.Therefore, further cause of the reported issue cannot be fully determined.The device remains in service with the customer and is functioning normally.
 
Event Description
The customer contacted physio-control to report that during a patient event their device prompted, "connect electrodes".The customer advised this occurred when attempting to shock a patient during a cardioversion procedure.In this state defibrillation therapy would not be available to a patient if needed.The customer advised that the defibrillation electrodes were replaced and the procedure was completed.There was no adverse patient outcome reported.
 
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Brand Name
LIFEPAK(R) 20 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 Key12073235
MDR Text Key258651878
Report Number0003015876-2021-01298
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873813782
UDI-Public00883873813782
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 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000067
Was Device Available for Evaluation? No
Date Manufacturer Received09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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