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	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2018
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 powered off by itself while attempting to charge, in order to shock.The customer advised that while charging the device, its display went blank.Medical personnel then rebooted the device and it functioned normally with no further discrepancies observed.The reporter advised that the reported issue led to an approximately four (4) minute delay in providing care to the patient; however, the patient was treated successfully.The patient, a (b)(6) male, was receiving coronary artery bypass graft surgery when the reported issue occurred.The patient survived the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device powered off by itself while attempting to charge, in order to shock.The customer advised that while charging the device, its display went blank.Medical personnel then rebooted the device and it functioned normally with no further discrepancies observed.The reporter advised that the reported issue led to an approximately four (4) minute delay in providing care to the patient; however, the patient was treated successfully.The patient, a (b)(6) male, was receiving coronary artery bypass graft surgery when the reported issue occurred.The patient survived the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.The customer was provided with a replacement device.Physio-control determined that the 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.
Additional Manufacturer Narrative
Section h7 of supplemental 001 medwatch report indicates: remedial action initiated - blank.Section h7 of supplemental 001 medwatch report should indicate: remedial action initiated - recall.Section h9 of supplemental 001 medwatch report indicates: correction/removal rpt number - blank.Section h9 of supplemental 001 medwatch report should indicate: correction/removal rpt number -(b)(4).
Event or Problem Description
The customer contacted physio-control to report that their device powered off by itself while attempting to charge, in order to shock.The customer advised that while charging the device, its display went blank.Medical personnel then rebooted the device and it functioned normally with no further discrepancies observed.The reporter advised that the reported issue led to an approximately four (4) minute delay in providing care to the patient; however, the patient was treated successfully.The patient, a 67 year-old male, was receiving coronary artery bypass graft surgery when the reported issue occurred.The patient survived the reported event.

• 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: 7857023
• Report Number: 0003015876-2018-01479
• Device Sequence Number: 13787624
• Product Code: MKJ
• UDI-Device Identifier: 00883873912126
• UDI-Public: 00883873912126
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/24/2020

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: 99577-001221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 01/21/2020
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 12/21/2018; 01/24/2020
• 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: 67 YR
• Patient Weight: 96