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	08/22/2018
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 would not shock during a cardiac arrest call.The customer advised that the device would not shock during two (2) attempts.Medical personnel had to call for a backup device.Once the backup device arrived, it was connected to the patient to continue care.There was no adverse effects to the patient as a result of the reported issue, as the backup device was used to continue patient care.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and was able to duplicate the reported issue.Physio determined that the cause of the reported issue was due to the therapy pcb assembly.Physio replaced the 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 further evaluated the removed therapy pcb assembly and determined the cause of the reported issue was due to a transistor, designator q7 on the h-bridge that was shorted.This short caused the device to deliver monophasic shocks and intermittently would not shock when prompted.
Event or Problem Description
The customer contacted physio-control to report that their device would not shock during a cardiac arrest call.The customer advised that the device would not shock during two (2) attempts.Medical personnel had to call for a backup device.Once the backup device arrived, it was connected to the patient to continue care.There was no adverse effects to the patient as a result of the reported issue, as the backup device was used to continue patient care.

• 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: 7879353
• Report Number: 0003015876-2018-01533
• Device Sequence Number: 2076995
• Product Code: MKJ
• UDI-Device Identifier: 00883873871805
• UDI-Public: 00883873871805
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 99577-001946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1