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

Model Number	15
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with all the available patient information.Patient fields in which information was not provided were intentionally left blank.Physio-control evaluated the customer's device and was unable to duplicate the reported issue.Physio did observe an event code logged in the device's memory that is indicative of a failure of the device to deliver energy; however, the event code was not logged on the date of the reported event.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 their device failed to deliver a shock to a patient when the user pressed the shock button.The shock button was pressed a second time and then a shock was successfully delivered to the patient.As a result, defibrillation therapy may be delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Physio-control has determined the cause of the reported issue was that the shock switch located on the main keypad assembly was out of tolerance due to excessive resistance.When this issue occurs, an event code will be logged in the device's memory following a failure of the device to deliver defibrillation energy.
Event or Problem Description
The customer contacted physio-control to report that their device failed to deliver a shock to a patient when the user pressed the shock button.The shock button was pressed a second time and then a shock was successfully delivered to the patient.As a result, defibrillation therapy may be delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.

• 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: 11408355
• Report Number: 0003015876-2021-00513
• Device Sequence Number: 11733076
• Product Code: MKJ
• UDI-Device Identifier: 00883873912805
• UDI-Public: 00883873912805
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 99577-001216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3015876-11/18/2019-001C
• Patient Sequence Number: 1
• Patient Age: 76 YR