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

Model Number	15
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio-control then replaced the main keypad assembly and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.Based on the information available, physio-control has determined that it¿s reasonable to conclude that the likely 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 had failed a user test.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that it had logged an event code in the memory which is related to a potential failure of the device to deliver defibrillation energy.
Additional Manufacturer Narrative
Initial report sent to fda of the initial mdr should have indicated ¿ no.
Event or Problem Description
The customer contacted physio-control to report that their device had failed a user test.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that it had logged an event code in the memory which is related to a potential failure of the device to deliver defibrillation energy.
Additional Manufacturer Narrative
This product complaint requires a supplemental mdr to document that field action number 301587611/18/2019-001c is relevant to the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device had failed a user test.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that it had logged an event code in the memory which is related to a potential failure of the device to deliver defibrillation energy.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 7848483
• Report Number: 0003015876-2018-01461
• Device Sequence Number: 1574224
• Product Code: MKJ
• UDI-Device Identifier: 00883873979419
• UDI-Public: 00883873979419
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2020

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: 99577-000056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 11/18/2019; 04/02/2020
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 11/21/2019; 04/02/2020
• 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