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

Model Number	20
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Physio-control performed an initial evaluation of the customers device and was unable to duplicate the reported issue.Physio-control performed an initial clinical review of the available event details and determined it is unknown if the device contributed to the reported adverse consequences.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted physio-control to report that when applying therapy shock to the patient their device screen went green and was not able to provide therapy shock.The customer reported adverse consequences requiring them to gather another monitor to perform therapy measures.
Additional Manufacturer Narrative
Physio-control further evaluate the device and was unable to determine root cause.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that when applying therapy shock to the patient their device screen went green and was not able to provide therapy shock.The customer reported adverse consequences requiring them to gather another monitor to perform therapy measures.

• Brand Name: LIFEPAK® 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: 9898069
• Report Number: 0003015876-2020-00443
• Device Sequence Number: 14102394
• Product Code: MKJ
• UDI-Device Identifier: 00883873813812
• UDI-Public: 00883873813812
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 99402-000065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention