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

Catalog Number	99400-000387
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and was unable to duplicate the reported issue.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.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly shut down without switching to the second battery.In this state the device would be inoperable and defibrillation therapy would not be available if needed this issue is patient related; however there was no adverse patient outcome reported.
Additional Manufacturer Narrative
Physio-control received additional patient information from the customer.The customer provided physio-control with all the available patient information and the information has been added to block a.Patient fields in which information is not provided were intentionally left blank.Physio downloaded the device's electronic records from the event for review and was able to verify the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly shut down without switching to the second battery.In this state the device would be inoperable and defibrillation therapy would not be available if needed this issue is patient related; however there was no adverse patient outcome reported.

• Brand Name: LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES
• Common Device Name: AUTOMATIC EXTERNAL DEFIBRILLATOR (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 9593868
• Report Number: 0003015876-2020-00086
• Device Sequence Number: 19644523
• Product Code: MKJ
• UDI-Device Identifier: 00721902148613
• UDI-Public: 00721902148613
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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 Catalogue Number: 99400-000387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR