MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE

Model Number	20
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.Physio will make unrelated repairs to the device and physio will replace the device's user interface to resolve the reported issue.After observing proper device operation through functional and performance testing, the device will be returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device had a cracked screen and a white display.A white display can be indicative of a device lock up condition.As a result, defibrillation therapy may be unavailable, if it is needed.There was no patient involvement in this event.
Additional Manufacturer Narrative
Physio-control further determined that the cause of the reported issue was due to a cracked lcd.
Event or Problem Description
The customer contacted physio-control to report that their device had a cracked screen and a white display.A white display can be indicative of a device lock up condition.As a result, defibrillation therapy may be unavailable, if it is needed.There was no patient involvement in this event.

• Brand Name: LIFEPAK 20 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: 10788567
• Report Number: 0003015876-2020-01639
• Device Sequence Number: 16869768
• Product Code: MKJ
• UDI-Device Identifier: 00883873813744
• UDI-Public: 00883873813744
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2021

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: 20
• Device Catalogue Number: 99402-000016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 08/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1