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

Model Number	15
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that they were using their device during a patient event and it wouldn't recognize the attached defibrillation electrodes.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information was not provided were intentionally left blank.Stryker 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 stryker to report that they were using their device during a patient event and it wouldn't recognize the attached defibrillation electrodes.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
The customer provided stryker with the device serial number and some of the patient information.Fields d4, a2, a3, and a4 have been updated.
Additional Manufacturer Narrative
The customer provided stryker with additional information on the reported issue.It was determined that the cause of the reported issue was due to the device and electrodes being improperly stored outside in the cold.
Event or Problem Description
The customer contacted stryker to report that they were using their device during a patient event and it wouldn't recognize the attached defibrillation electrodes.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16194812
• Report Number: 0003015876-2023-00091
• Device Sequence Number: 20350132
• Product Code: MKJ
• UDI-Device Identifier: 00883873911747
• UDI-Public: 00883873911747
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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): 05/08/2023

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: 99577-001245
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 03/02/2023; 04/10/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/24/2023; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 64 KG