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	Failure To Run On AC/DC (1001)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control continues to investigate the reported failure 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 when attempting to power on their device, it will not power on.The device will not power on when plugged into ac and the device has two fully charged batteries installed.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that when attempting to power on their device, it will not power on.The device will not power on when plugged into ac and the device has two fully charged batteries installed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device but was unable to duplicate the reported power issue.Physio downloaded and reviewed the electronic records from the customer¿s device and verified the reported issue.Physio observed that the device was not communicating with the ac power adapter while in use in a king air 200 fixed wing air ambulance connected to that ambulances static inverter.Physio determined that the likely cause of the reported issue was due to a failure of the ac power adapter to communicate with the device as well as ac power line artifact from their "clipped sine wave" inverter on the airplane.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.

• 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: 7566506
• Report Number: 0003015876-2018-00864
• Device Sequence Number: 16816151
• Product Code: MKJ
• UDI-Device Identifier: 00883873911723
• UDI-Public: 00883873911723
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

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 Model Number: 15
• Device Catalogue Number: 99577-001247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1