MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; 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	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the device's therapy pcb assembly to resolve the reported issue.After observing proper device operation 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 they were using this device on a patient during a synchronized cardioversion procedure.When they attempted to deliver a shock to the patient, the device would not deliver a shock.The customer also reported that the device logged event codes in its memory that can be indicative of a failure to deliver defibrillation energy and a delivery of a monophasic shock.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Additional Manufacturer Narrative
Physio-control further evaluated the removed therapy pcb assembly and determined that the cause of the reported issue was due to a shorted transistor, designated q8.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient during a synchronized cardioversion procedure.When they attempted to deliver a shock to the patient, the device would not deliver a shock.The customer also reported that the device logged event codes in its memory that can be indicative of a failure to deliver defibrillation energy and a delivery of a monophasic shock.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient during a synchronized cardioversion procedure.When they attempted to deliver a shock to the patient, the device would not deliver a shock.The customer also reported that the device logged event codes in its memory that can be indicative of a failure to deliver defibrillation energy and a delivery of a monophasic shock.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• 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: 8242068
• Report Number: 0003015876-2019-00078
• Device Sequence Number: 11158628
• Product Code: MKJ
• UDI-Device Identifier: 00883873871782
• UDI-Public: 00883873871782
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2020

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: 99577-001948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/27/2019; 03/28/2020
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/22/2019; 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1