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 Patient Involvement (2645)
Date of Event	02/18/2019
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 charged and delivered defibrillation energy successfully.After the delivery of energy the screen remained blacked out and their device appeared to be locked up, when this occurred the leds on the device were illuminated, however the keypad buttons were unresponsive.The customer advised that the device was shocked 10 times, it was after the 10th shock that the device lock up occurred.This event took place during scheduled testing of the customer's device.There was no patient use associated with the reported failure.
Event or Problem Description
The customer contacted physio-control to report that their device charged and delivered defibrillation energy successfully.After the delivery of energy the screen remained blacked out and their device appeared to be locked up, when this occurred the leds on the device were illuminated, however the keypad buttons were unresponsive.The customer advised that the device was shocked 10 times, it was after the 10th shock that the device lock up occurred.This event took place during scheduled testing of the customer's device.There was no patient use associated with the reported failure.
Additional Manufacturer Narrative
Initial reporter name and address of the initial medwatch report indicates: initial reporter address ¿(b)(6).Initial reporter name and address of the initial medwatch report should indicate: initial reporter address ¿ (b)(6).Additional information: physio-control was notified that the customer submitted a voluntary medwatch (medsun) form reference uf/importer report #(b)(4).As a result, has been updated to ¿yes.¿.
Additional Manufacturer Narrative
Physio-control evaluated the customer¿s device but was unable to duplicate the reported issue.After a technical service update was completed, proper device operation was observed through functional and performance testing, 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 charged and delivered defibrillation energy successfully.After the delivery of energy the screen remained blacked out and their device appeared to be locked up, when this occurred the leds on the device were illuminated, however the keypad buttons were unresponsive.The customer advised that the device was shocked 10 times, it was after the 10th shock that the device lock up occurred.This event took place during scheduled testing of the customer's device.There was no patient use associated with the reported failure.

• 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: 8402310
• Report Number: 0003015876-2019-00403
• Device Sequence Number: 1990483
• Product Code: MKJ
• UDI-Device Identifier: 00883873911815
• UDI-Public: 00883873911815
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,Followup
• Report Date (Section B): 04/23/2019

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: 99577-001238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 03/11/2019; 04/23/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 03/20/2019; 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1