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

Catalog Number	97400-001373
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The biomedical engineer evaluated their device and was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to 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
The customer, a biomedical engineer contacted physio-control to report that their device would not display the joule energy level during a patient event.The customer advised that the energy level was not displayed on their device and they were unable to change the energy (it is unknown if they were unable to change the energy level due to a control issue or because they were unable to see the energy level being selected).They were able to charge the device for defibrillation and successfully shock the patient, however they did not know what energy level was delivered.In addition, the customer advised that their device service indicator had illuminated when the defibrillation electrodes were connected to the patient.In this state, wrong defibrillation therapy would be delivered to the patient.This issue is patient related; however the customer advised that there was no adverse patient outcome.Physio-control contacted the customer in order to obtain additional information about both the patient and the event, however, the customer was unable provide further information.

• Brand Name: LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
• 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: 8053229
• Report Number: 0003015876-2018-01865
• Device Sequence Number: 1586176
• Product Code: MKJ
• UDI-Device Identifier: 00883873950968
• UDI-Public: 00883873950968
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• 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): 11/08/2018

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: 97400-001373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1