MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After observing proper device operation 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 they were using this device on a patient and when they shocked the patient the device's display went completely black and the device's was not responding.There was a back up device available but it is unknown whether or not that device was used.As a result, defibrillation therapy may have been unavailable, if it was needed.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 downloaded the device's electronic records from the event for review and verified the reported issue.Physio-control has determined that the likely cause of the reported issue was due to a field programmable gate array component (¿fpga¿) on the system pcb assembly.Timing issues in the fpga firmware may intermittently prevent a required system reboot following a defibrillator shock which results in the lockup issue.During the evaluation, the device lockup condition occurred once in every 800 to 1200 defibrillator discharge cycles.New fpga firmware has been created to resolve the timing issues that were identified.Validation testing of the new fpga firmware has confirmed that the updated firmware is effective in correcting intermittent device lockup issue following a defibrillator shock has been corrected.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient and when they shocked the patient the device's display went completely black and the device's was not responding.There was a back up device available but it is unknown whether or not that device was used.As a result, defibrillation therapy may have been unavailable, if it was needed.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: 8372601
• Report Number: 0003015876-2019-00324
• Device Sequence Number: 1203163
• Product Code: MKJ
• UDI-Device Identifier: 00883873911815
• UDI-Public: 00883873911815
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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: 02/13/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3015876-12/28/2018-001-C
• Patient Sequence Number: 1