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

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control provided the customer with technical assistance.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.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that they attempted to power the device on by pressing the on/off button.The device started to turn on, but as soon as the on/off button was released, the device unexpectedly powered off.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the device's ac power adapter and tightened the nut on the internal side of the system connector.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Physio-control further evaluated the removed ac power adapter and did not observe any issues with this part.A further cause for the reported issue could not be conclusively determined.
Event or Problem Description
The customer contacted physio-control to report that they attempted to power the device on by pressing the on/off button.The device started to turn on, but as soon as the on/off button was released, the device unexpectedly powered off.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: 8466325
• Report Number: 0003015876-2019-00547
• Device Sequence Number: 3026653
• Product Code: MKJ
• UDI-Device Identifier: 00883873911815
• UDI-Public: 00883873911815
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/18/2019

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: 99577-001238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1