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	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 contacted physio-control to report that their device powered off by itself during a patient event.This issue occurred when taking a blood pressure measurement and a 12 lead ecg reading.This issue is patient related; however there was no adverse patient outcome reported by the customer.Physio-control made multiple attempts to contact the customer in order to obtain additional information about both the patient and the event, but has been unsuccessful.
Additional Manufacturer Narrative
Physio-control evaluated the customer¿s device but 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 multiple inappropriate losses of power.It was observed that the battery used during the event had a broken locking tab.The device batteries were replaced, and then 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.
Event or Problem Description
The customer contacted physio-control to report that their device powered off by itself during a patient event.This issue occurred when taking a blood pressure measurement and a 12 lead ecg reading.This issue is patient related; however there was no adverse patient outcome reported by the customer.Physio-control made multiple attempts to contact the customer in order to obtain additional information about both the patient and the event, but has been unsuccessful.

• 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: 7672155
• Report Number: 0003015876-2018-01063
• Device Sequence Number: 2643229
• Product Code: MKJ
• UDI-Device Identifier: 00883873871645
• UDI-Public: 00883873871645
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 99577-001962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1