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	03/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer, a biomedical engineer, advised that he evaluated the device but was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing the device was placed back into service for use.The device was not returned to physio-control for evaluation.Based on the available information, the following is the likely cause of the reported event: the likely cause of the reported issue has been determined to be 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.Device not evaluated by manufacturer.
Event or Problem Description
The customer, a biomedical engineer, contacted physio-control to report that after delivering one (1) shock to the patient that their device's display went blank, while the led's on the main keypad remained lit.Medical personnel had advised the biomed that the device's display remained blank until they removed and reinstalled both batteries, after which the device powered on and proper operation was observed.The reported device behavior is indicative of a device lockup condition that could delay or prevent defibrillation.The customer advised that the patient had an implantable cardioverter-defibrillator (icd).Medical personnel had reported that the implantable icd shocked the patient during the event, but could not recall how many times.A backup device was obtained and used to continue patient care.The customer advised that the patient survived the event and that no further information about the patient was available.There were no reports of adverse effects to the patient as a result of the reported issue.
Event or Problem Description
The customer, a biomedical engineer, contacted physio-control to report that after delivering one (1) shock to the patient that their device's display went blank, while the led's on the main keypad remained lit.Medical personnel had advised the biomed that the device's display remained blank until they removed and reinstalled both batteries, after which the device powered on and proper operation was observed.The reported device behavior is indicative of a device lockup condition that could delay or prevent defibrillation.The customer advised that the patient had an implantable cardioverter-defibrillator (icd).Medical personnel had reported that the implantable icd shocked the patient during the event, but could not recall how many times.A backup device was obtained and used to continue patient care.The customer advised that the patient survived the event and that no further information about the patient was available.There were no reports of adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
As a result of this investigation, physio-control has initiated a field corrective action (reference corrections and removals number 3015876-12/28/2018-001-c).

• 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: 8185453
• Report Number: 0003015876-2018-02165
• Device Sequence Number: 19164259
• Product Code: MKJ
• UDI-Device Identifier: 00883873911556
• UDI-Public: 00883873911556
• 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: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: 99577-001263
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2015
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/17/2019
• 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