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

Model Number 15

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with all the available patient information.Patient fields in which information was not provided were intentionally left blank.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 Description

The customer contacted physio-control to report that their device did not recognize the paddles lead as connected during a patient event.As a result, defibrillation therapy may have been unavailable, if needed.The customer reported the patient involved in the reported event is deceased; however, the paramedics at the scene confirmed that the device use did not contribute to the outcome of the patient.

Manufacturer Narrative

Physio-control evaluated the customer's device and was unable to duplicate the reported issue.Physio replaced the device's therapy pcb and power pcb assemblies as a precaution.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Physio-control further evaluated the removed therapy pcb and power pcb assemblies.No issues were observed with either component.The cause of the reported issue could not be determined.

Event Description

The customer contacted physio-control to report that their device did not recognize the paddles lead as connected during a patient event.As a result, defibrillation therapy may have been unavailable, if needed.The customer reported the patient involved in the reported event is deceased; however, the paramedics at the scene confirmed that the device use did not contribute to the outcome of the patient.

• Brand Name: LIFEPAK 15 DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 11305213
• MDR Text Key: 231211072
• Report Number: 0003015876-2021-00352
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873871683
• UDI-Public: 00883873871683
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 113