MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
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 evaluated the customers device and was unable to duplicate the reported failure to deliver defibrillation issue.Physio-control reviewed the device data and verified the reported error code issue.Physio replaced the device's therapy pcb assembly to resolve the reported issue.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 their device did not shock during a code.This issue is patient related; however there was no adverse event reported.The customer stated they used a different defib during the procedure, so there were no adverse consequences.Upon evaluation of the customer¿s device, physio-control observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver energy.
Additional Manufacturer Narrative
Section h6 investigation findings of the initial medwatch report indicates: blank section 6 investigation findings of the initial medwatch report should indicate: operational problem.
Event or Problem Description
The customer contacted physio-control to report that their device did not shock during a code.This issue is patient related; however there was no adverse event reported.The customer stated they used a different defib during the procedure, so there were no adverse consequences.Upon evaluation of the customer¿s device, physio-control observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver energy.

• Brand Name: LIFEPAK 15 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: 11020601
• Report Number: 0003015876-2020-01890
• Device Sequence Number: 11481968
• Product Code: MKJ
• UDI-Device Identifier: 00883873871812
• UDI-Public: 00883873871812
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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): 03/23/2021

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: 15
• Device Catalogue Number: 99577-001945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1