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

Model Number	20
Medical Device Problem Codes	Failure to Power Up (1476); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.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 unexpectedly powered off and would not power back on during a patient event.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
The customer provided physio-control with the patient information.Fields a1, a2, a3, a4, and b7 have been updated.
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly powered off and would not power back on during a patient event.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.H3 other text: device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly powered off and would not power back on during a patient event.There were no reports of any adverse effects to the patient as a result of the reported issue.

• 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: 10926016
• Report Number: 0003015876-2020-01792
• Device Sequence Number: 1508087
• Product Code: MKJ
• UDI-Device Identifier: 00883873813799
• UDI-Public: 00883873813799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 09/16/2021

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: 99402-000033
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/14/2020; 08/22/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/18/2020; 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 65