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

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 powered off by itself during a patient event.The customer advised that after successfully shocking a patient, the device shutoff.It took several attempts of pressing the power button in order to power device back on.They were able to power their device back on, however , it is unknown what the delay was in powering the device back on.A secondary monitor was being used on the patient and they were able to immediately read the patient's ecg through that monitor.This issue is patient related; however there was no adverse patient outcome reported.Physio-control contacted the customer in order to obtain additional information about both the patient and the event.However, the customer was unable to provide further details.
Additional Manufacturer Narrative
Physio-control evaluated the customer¿s device but was unable to duplicate the reported issue.Physio downloaded the electronic records from the customer¿s device and was unable to confirm the reported issue.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device powered off by itself during a patient event.The customer advised that after successfully shocking a patient, the device shutoff.It took several attempts of pressing the power button in order to power device back on.They were able to power their device back on, however , it is unknown what the delay was in powering the device back on.A secondary monitor was being used on the patient and they were able to immediately read the patient's ecg through that monitor.This issue is patient related; however there was no adverse patient outcome reported.Physio-control contacted the customer in order to obtain additional information about both the patient and the event.However, the customer was unable to provide further details.

• 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: 8347976
• Report Number: 0003015876-2019-00283
• Device Sequence Number: 1994888
• Product Code: MKJ
• UDI-Device Identifier: 00883873911730
• UDI-Public: 00883873911730
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 04/08/2019

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: 99577-001246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1