MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	99400-002505
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 unexpectedly powered itself off.The crew had to press the power button to turn the device back on.There was no patient use associated with the reported issue.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device but was unable to duplicate the reported issue.Physio-control did observe that after powering the device on that its display was faint and would eventually go blank.When this occurred, however, the device was still operational.Physio-control then replaced the device's display assembly and completed other, unrelated, repairs.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.The cause of the reported failure to power on could not be determined; however, it is possible that what the device users observed was the display going blank and not an actual loss of power.
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly powered itself off.The crew had to press the power button to turn the device back on.There was no patient use associated with the reported issue.

• Brand Name: LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES
• 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: 8501873
• Report Number: 0003015876-2019-00631
• Device Sequence Number: 1884657
• Product Code: MKJ
• UDI-Device Identifier: 00885074269252
• UDI-Public: 00885074269252
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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 Catalogue Number: 99400-002505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1