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	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
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 was not shocking properly during an event.The customer advised that personnel attempted to change the joules but that it continued to not work.The customer advised that he had no further details about the reported issue.The customer further advised that there were no adverse effects to the patient as a result of the reported issue.A backup device, also a lifepak 15, was available and used to continue patient care.The customer advised that he had no further information regarding the patient.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and was unable to duplicate the reported issue.Physio downloaded the device's electronic records from the event for review and was able to verify the powered itself off when the shock button was pressed.The device was powered back on and the user was able to successfully deliver a shock less than 2 minutes later.This issue is consistent with an evaluation performed by physio-control performed on another device.When the issue occurs, the device does not deliver energy when prompted and disarms itself after being rebooted.Physio-control replaced the device's therapy pcb assembly to resolve the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the removed therapy pcb assembly and was unable to determine a further component root cause for the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device was not shocking properly during an event.The customer advised that personnel attempted to change the joules but that it continued to not work.The customer advised that he had no further details about the reported issue.The customer further advised that there were no adverse effects to the patient as a result of the reported issue.A backup device, also a lifepak 15, was available and used to continue patient care.The customer advised that he had no further information regarding the patient.

• 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: 7994870
• Report Number: 0003015876-2018-01764
• Device Sequence Number: 19179140
• Product Code: MKJ
• UDI-Device Identifier: 00883873872093
• UDI-Public: 00883873872093
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/07/2019

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: 99577-001930
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1