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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
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 locked up after successfully delivering for defibrillation energy to a patient.The customer advised that after their device successfully shocked the patient, their device locked up.The user had to remove the batteries in order to turn the device off.After re-installing the batteries they were able to power the device back on.The patient was successfully converted during the defibrillation shock.The patient survived the event, however the customer was unable to provide any further information on the event or the patient.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.Physio 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 engineering evaluation, the device lockup condition occurred once in every 800 to 1200 defibrillator discharge cycles.New fpga firmware was installed and then proper device operation was observed 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 their device locked up after successfully delivering for defibrillation energy to a patient.The customer advised that after their device successfully shocked the patient, their device locked up.The user had to remove the batteries in order to turn the device off.After re-installing the batteries they were able to power the device back on.The patient was successfully converted during the defibrillation shock.The patient survived the event, however the customer was unable to provide any further information on the event or 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: 8774338
• Report Number: 0003015876-2019-01175
• Device Sequence Number: 11288396
• Product Code: MKJ
• UDI-Device Identifier: 00883873912836
• UDI-Public: 00883873912836
• 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: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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: 99577-001213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 48