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

Model Number	EXPRESS
Medical Device Problem Codes	Power Problem (3010); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer will be provided with a replacement device.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 would not provide any voice prompts.The customer also advised that their device all three icons (charge-pak, attention, and service wrench).In this state, the user would not be able to use the device properly on a patient if needed and the device may not be able to provide sufficient defibrillation therapy, if necessary.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device would not provide any voice prompts.The customer also advised that their device all three icons (charge-pak, attention, and service wrench).In this state, the user would not be able to use the device properly on a patient if needed and the device may not be able to provide sufficient defibrillation therapy, if necessary.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.Physio observed that the device was unable to complete boot up and powered off after 10 seconds.Physio determined that the cause of the reported issue was due to crystal oscillator, designator y1 on the digital pcb assembly.Y1 was inoperative.The device was destructively tested.

• Brand Name: LIFEPAK EXPRESS(R) 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: 10080358
• Report Number: 0003015876-2020-00663
• Device Sequence Number: 11729226
• Product Code: MKJ
• UDI-Device Identifier: 00883873823644
• UDI-Public: 00883873823644
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P160012
• 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
• Report Date (Section B): 08/21/2020

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: Lay User/Patient
• Device Model Number: EXPRESS
• Device Catalogue Number: 99427-000129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1