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

Model Number	20
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device was unable to deliver a shock during a patient event.The customer advised that the device was able to charge for defibrillation but not deliver a shock.The customer also stated the device was giving a connect electrodes message.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however there was no adverse patient outcome reported.
Additional Manufacturer Narrative
The customer received a replacement device.Physio-control evaluated the customer's device and was unable to duplicate the reported issue.Physio downloaded the electronic records from the device and verified the reported issue.Physio observed that the a charge was removed and "connect electrodes" message appeared while cpr was being administered.The device was scrapped.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device was unable to deliver a shock during a patient event.The customer advised that the device was able to charge for defibrillation but not deliver a shock.The customer also stated the device was giving a connect electrodes message.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however 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: 11761710
• Report Number: 0003015876-2021-00974
• Device Sequence Number: 3724659
• Product Code: MKJ
• UDI-Device Identifier: 00883873813799
• UDI-Public: 00883873813799
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/07/2021

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: 99402-000033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1