MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	20
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 12073235
• Report Number: 0003015876-2021-01298
• Device Sequence Number: 3593108
• Product Code: MKJ
• UDI-Device Identifier: 00883873813782
• UDI-Public: 00883873813782
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 99402-000067
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1