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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and was unable to duplicate the reported issue.Physio downloaded the electronic records from the customer¿s device and was able to confirm that their device experienced an inappropriate reboot.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing, and the device was returned to the customer for 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 powered off and on by itself during a patient event.This issue occurred when the customer pressed the code summary button.The patient was being monitored only.This issue is patient related; however there was no adverse patient outcome reported by the customer.No further details were provided by the customer.Physio-control has attempted to contact the customer for further information on the event and patient, but has been unsuccessful.
Additional Manufacturer Narrative
The customer provided further information on the event and the patient.
Event or Problem Description
The customer contacted physio-control to report that their device powered off and on by itself during a patient event.This issue occurred when the customer pressed the code summary button.The patient was being monitored only.A backup device was not available and was not necessary.The crew was able to care for the patient with the device.The issue with the device affected only the documentation but not the patient care.The patient, an 87 year old female was successfully transported to the hospital.This issue is patient related; however the customer advised there was no adverse outcome to the patient.The patient did survive to the hospital, however the customer did not know the final outcome.

• 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: 8520962
• Report Number: 0003015876-2019-00671
• Device Sequence Number: 1465548
• Product Code: MKJ
• UDI-Device Identifier: 00883873911747
• UDI-Public: 00883873911747
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 99577-001245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 61