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 /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control performed an initial evaluation of the device and verified the reported issue.The customer will be sent a replacement device.Physio-control continues to investigate the reported issue 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 displayed a solid white screen.A white display can be indicative of a device lock up condition.As a result, defibrillation therapy may be unavailable, if it is needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control provided a replacement device.Physio replicated the reported issue after the device was soaked in a temperature chamber for 4 hours at 50 degrees c.The cause was heat sensitivity of the single board computer (sbc) on the system pcb assembly.
Event or Problem Description
The customer contacted physio-control to report that their device displayed a solid white screen.A white display can be indicative of a device lock up condition.As a result, defibrillation therapy may be unavailable, if it is needed.There was no report of 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: 9584115
• Report Number: 0003015876-2020-00080
• Device Sequence Number: 16277318
• Product Code: MKJ
• UDI-Device Identifier: 00883873871614
• UDI-Public: 00883873871614
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 99577-001965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1