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	02/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The third party service agent performed an initial evaluation of the customer¿s device but was unable to duplicate 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
A third-party service agent contacted physio-control to report that their customer's device had unexpectedly powered off twice during resuscitation of a patient.Physio-control contacted the customer in order to obtain additional information about the patient and event; however, no response was received.
Additional Manufacturer Narrative
Physio-control further evaluated the customer's device and was unable to reproduce the reported issue.The electronic record were reviewed and it was verified that the device had experienced two unexpected losses of power.After replacing the battery pins and the smart battery contact as preventive measure, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.The cause of the reported issue could not be determined.The customer later confirmed that the patient was a 40-year-old male and the event date was (b)(6) 2019.
Event or Problem Description
A third-party service agent contacted physio-control to report that their customer's device had unexpectedly powered off twice during resuscitation of a patient.Physio-control contacted the customer in order to obtain additional information about the patient and event; however, no response was received.
Additional Manufacturer Narrative
The initial medwatch report should indicate: manufacturing date ¿ 10/06/2015.
Event or Problem Description
A third-party service agent contacted physio-control to report that their customer's device had unexpectedly powered off twice during resuscitation of a patient.Physio-control contacted the customer in order to obtain additional information about the patient and event; however, no response was 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: 8388206
• Report Number: 0003015876-2019-00369
• Device Sequence Number: 2051277
• Product Code: MKJ
• UDI-Device Identifier: 00883873911679
• UDI-Public: 00883873911679
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2019

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: 99577-001252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 04/07/2019; 12/10/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 05/01/2019; 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR