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 Energy (1211)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control reviewed the device data and verified the reported issue.Physio erased the event codes from the device memory and did not observe them return during device testing.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
Physio-control was performing a field action when an event code was noted.The event code logged in the devices memory can be indicative of a failure of the device to deliver defibrillation energy if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
This product complaint requires a supplemental mdr to document that field action number (b)(4) is relevant to the reported issue.
Event or Problem Description
Physio-control was performing a field action when an event code was noted.The event code logged in the devices memory can be indicative of a failure of the device to deliver defibrillation energy if needed.There was no patient use associated with the reported event.

• 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: 8957732
• Report Number: 0003015876-2019-01476
• Device Sequence Number: 11287464
• Product Code: MKJ
• UDI-Device Identifier: 00883873911730
• UDI-Public: 00883873911730
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: 99577-001246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 12/09/2019
• 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