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	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control performed an initial evaluation of the customer's device and verified the reported issue.Physio-control continues to investigate the reported issue 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, a biomedical engineer, contacted physio-control to report that during an event their device powered off by itself multiple times.The customer advised that medical personnel were in the process of implanting and programming a pacemaker when the reported issue occurred.Medical personnel stated that the device was plugged into ac power at the time and had two fully charged batteries installed.The device was being used to monitor the patient's ecg waveform during the procedure.The customer stated that each time the device lost power, medical personnel would power it back on, only to have it power off again.They believed this occurred three times during the event.No further details were provided.Physio-control has made multiple attempts to contact the customer in order to obtain additional information about both the patient and the event; however, no response has been received.
Additional Manufacturer Narrative
Physio-control replaced the device's ac power adapter (acpa) to resolve the reported issue.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.
Event or Problem Description
The customer, a biomedical engineer, contacted physio-control to report that during an event their device powered off by itself multiple times.The customer advised that medical personnel were in the process of implanting and programming a pacemaker when the reported issue occurred.Medical personnel stated that the device was plugged into ac power at the time and had two fully charged batteries installed.The device was being used to monitor the patient's ecg waveform during the procedure.The customer stated that each time the device lost power, medical personnel would power it back on, only to have it power off again.They believed this occurred three times during the event.No further details were provided.Physio-control has made multiple attempts to contact the customer in order to obtain additional information about both the patient and the event; however, no response has been received.

• 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: 8122349
• Report Number: 0003015876-2018-02031
• Device Sequence Number: 251679
• Product Code: MKJ
• UDI-Device Identifier: 00883873912836
• UDI-Public: 00883873912836
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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,Followup
• Report Date (Section B): 01/28/2019

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: 99577-001213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1