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

Model Number	15
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control performed an initial evaluation of the customer's device and verified the reported issue.The customer will receive a replacement device.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 re-boots itself approximately every 30 seconds and will not display ecg.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control further evaluated the customer's device and determined the cause for the reported issue was due to the system pcb assembly.The customer received a replacement device.Physio-control further evaluated the removed system pcb assembly and verified the reported issue.It was determined that the system pcb assembly caused the device to continually re-boot itself, ecg could not be displayed and the device could not charge and shock; however further cause could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device re-boots itself approximately every 30 seconds and will not display ecg.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device re-boots itself approximately every 30 seconds and will not display ecg.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Section e4 initial report sent to fda of the initial medwatch report indicates: blank section e4 initial report sent to fda of the initial medwatch report should indicate: no.

• 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: 8052250
• Report Number: 0003015876-2018-01861
• Device Sequence Number: 1787113
• Product Code: MKJ
• UDI-Device Identifier: 00883873872055
• UDI-Public: 00883873872055
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2020

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: UNK_MED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 12/17/2018; 01/30/2020
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 01/10/2019; 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1