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

Model Number	20
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 report that their device's display was completely white.A white display can be indicative of a device lock up condition.As a result, defibrillation therapy may be unavailable, if needed.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device's display was completely white.A white display can be indicative of a device lock up condition.As a result, defibrillation therapy may be unavailable, if needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and was unable to duplicate the reported issue, but the device would not complete the boot up process.Physio replaced the device's redux kit to resolve the issues.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The root cause of the issue was determined to be the integrated circuit, designator u61, being electrically shorted, causing the unit to lock up with a white screen and not complete boot-up.

• 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: 10554818
• Report Number: 0003015876-2020-01271
• Device Sequence Number: 3167768
• Product Code: MKJ
• UDI-Device Identifier: 00883873813737
• UDI-Public: 00883873813737
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/15/2020

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: 20
• Device Catalogue Number: 99402-000001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1