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 Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.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 their device on a patient and the display shut off after they tried to deliver defibrillation therapy.The customer later reported that the device was freezing during the event.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
The customer provided physio-control with the patient information.Patient information fields a1, a2, a3, and a4 have been updated.
Event or Problem Description
The customer contacted physio-control to report that they were using their device on a patient and the display shut off after they tried to deliver defibrillation therapy.The customer later reported that the device was freezing during the event.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Physio downloaded the device's electronic records from the event for review and was able to verify 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 their device on a patient and the display shut off after they tried to deliver defibrillation therapy.The customer later reported that the device was freezing during the event.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.

• 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: 10221055
• Report Number: 0003015876-2020-00829
• Device Sequence Number: 2404342
• Product Code: MKJ
• UDI-Device Identifier: 00883873911600
• UDI-Public: 00883873911600
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2020

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: 99577-001258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/21/2020; 08/21/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/19/2020; 09/17/2020
• 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
• Patient Age: 79 YR
• Patient Weight: 88