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

Model Number	15
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
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.Patient fields in which information is not provided were intentionally left blank.Physio-control evaluated the customer's device and verified the reported issue.Physio observed that the power button required to be pressed very had and for a long period to power on.Physio replaced the main keypad assembly and then observed proper device operation through functional and performance testing.The device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device would not power on during a patient event.The customer swapped devices at the scene.This issue is patient related; however there was no adverse patient outcome.
Event or Problem Description
The customer contacted physio-control to report that their device would not power on during a patient event.The customer swapped devices at the scene.This issue is patient related; however there was no adverse patient outcome.
Additional Manufacturer Narrative
The customer provided patient details.Section a and b have been updated as applicable.
Additional Manufacturer Narrative
Physio-control determined that the main keypad was worn, which caused the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device would not power on during a patient event.The customer swapped devices at the scene.This issue is patient related; however there was no adverse patient outcome.

• Brand Name: LIFEPAK(R) 15 MONITOR/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: 11842182
• Report Number: 0003015876-2021-01103
• Device Sequence Number: 11934386
• Product Code: MKJ
• UDI-Device Identifier: 00883873872024
• UDI-Public: 00883873872024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/30/2021

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: 15
• Device Catalogue Number: 99577-001937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 05/26/2021; 07/26/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 05/27/2021; 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 57