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

Model Number	15
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The third party service agent evaluated the customer¿s device and was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
A third party service agent contacted physio-control to report that a customer's locked up during a patient event.The customer advised that after connecting the 12 leads ecg, the device froze.They attempted to power off the device, however none of the buttons were responding.The batteries in the device were removed and reinstalled, however the device was unable to power on.The batteries were again removed and reinstalled, they waited a few minutes and the device was able to power on to a normal state.During the troubleshooting of the device, a backup device was already on the scene and was used.The device was used for monitoring the patient only.This issue is patient related.The customer advised that the use of the device did not affect patient care.Physio-control contacted the customer in order to obtain additional information about both the patient and the event, however, the customer advised that no further details are available.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 8507125
• Report Number: 0003015876-2019-00646
• Device Sequence Number: 13913228
• Product Code: MKJ
• UDI-Device Identifier: 00883873911457
• UDI-Public: 00883873911457
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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: 99577-001268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1