MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; 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	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.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 unexpectedly powered off while they were using it to monitor a patient.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Additional Manufacturer Narrative
The customer provided physio-control with the patient information.Sections, a1, a2, a3, a4, and b7 have been updated.
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly powered off while they were using it to monitor a patient.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.

• 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: 8903768
• Report Number: 0003015876-2019-01371
• Device Sequence Number: 19512116
• Product Code: MKJ
• UDI-Device Identifier: 00883873911709
• UDI-Public: 00883873911709
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 99577-001249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 45