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

Model Number	15
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control performed an initial evaluation of the customer's device and verified the reported issue.Physio-control continues to investigate the reported failure 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 reported that they were using this device on a patient and were having display issues so they attempted to restart the device.When the device powered back on it locked up on the self-test screen.As a result defibrillation therapy may have been unavailable, if it was needed.The customer obtained a back up device and used that to continue patient care.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Physio-control determined that the cause of the reported issue was due to the device's system pcb assembly.At this time, this device cannot be repaired due to part obsolescence.The customer has received a loaner until a permanent solution for this complaint is identified.
Event or Problem Description
The customer contacted physio-control to reported that they were using this device on a patient and were having display issues so they attempted to restart the device.When the device powered back on it locked up on the self-test screen.As a result defibrillation therapy may have been unavailable, if it was needed.The customer obtained a back up device and used that to continue patient care.There were no reports of any adverse effects to the patient as a result of the reported issue.
Event or Problem Description
The customer contacted physio-control to reported that they were using this device on a patient and were having display issues so they attempted to restart the device.When the device powered back on it locked up on the self-test screen.As a result defibrillation therapy may have been unavailable, if it was needed.The customer obtained a back up device and used that to continue patient care.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Physio-control further evaluated the removed system pcb assembly and determined that the cause of the reported issue was due to an inoperative single board computer.The customer received a replacement device.

• 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: 8757835
• Report Number: 0003015876-2019-01148
• Device Sequence Number: 19451127
• Product Code: MKJ
• UDI-Device Identifier: 00883873987971
• UDI-Public: 00883873987971
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2020

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: 99577-000051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 10/16/2019; 10/22/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 11/11/2019; 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 90