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

Model Number	15
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and found the on/off button would not activate.Both power buttons measured excessive resistance, and process residue was visually observed between the dome and the gold trace.The main keypad was replaced to resolve the issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue is the main keypad.
Event or Problem Description
The customer contacted physio-control to report that the on/off button of their device was difficult to activate.There was no patient use reported with the event.Physio-control evaluated the device and found the on/off button was inoperable.In this state the device would be inoperable and defibrillation therapy would not be available if needed.
Event or Problem Description
The customer contacted physio-control to report that the on/off button of their device was difficult to activate.There was no patient use reported with the event.Physio-control evaluated the device and found the on/off button was inoperable.In this state the device would be inoperable and defibrillation therapy would not be available if needed.
Additional Manufacturer Narrative
Based on the available information, physio-control determined that the cause of the reported issue was due to the process residue/contamination on the main keypad assembly.

• 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: 10156372
• Report Number: 0003015876-2020-00754
• Device Sequence Number: 19658187
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2020

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: 99577-001216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1