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

Model Number	15
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the customer¿s device and the electronic device record and could not locate any record of the alleged malfunction.It should be noted that many patient records ran out of memory as the customer leaves the device on for days without 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 was unable to complete a defibrillation charge cycle when prompted on multiple occasions.There was no patient use reported with the event.
Event or Problem Description
The customer contacted physio-control to report that their device was unable to complete a defibrillation charge cycle when prompted on multiple occasions.There was no patient use reported with the event.
Additional Manufacturer Narrative
Section h10/11 of the initial medwatch report indicates: physio-control evaluated the customer's device and was unable to duplicate the reported issue.After proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the customer¿s device and the electronic device record and could not locate any record of the alleged malfunction.It should be noted that many patient records ran out of memory as the customer leaves the device on for days without use.The cause of the reported issue could not be determined.Section h10/11 of the initial medwatch report should indicate: physio-control evaluated the customer's device and was unable to duplicate the reported issue.The device's system pcb assembly was replaced as a precaution.After proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the customer¿s device and the electronic device record and could not locate any record of the alleged malfunction.It should be noted that many patient records ran out of memory as the customer leaves the device on for days without use.The cause of the reported issue could not be determined.

• 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: 9684651
• Report Number: 0003015876-2020-00178
• Device Sequence Number: 2668052
• Product Code: MKJ
• UDI-Device Identifier: 00883873871812
• UDI-Public: 00883873871812
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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 Model Number: 15
• Device Catalogue Number: 99577-001945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1