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

Model Number 15

Device Problem Failure to Sense (1559)

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

Event Date 09/01/2021

Event Type  malfunction  

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 customers device and was unable to duplicate the reported issue.Physio-control reviewed the device data and verified the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.

Event Description

The customer contacted physio-control to report that their device had an intermittent connection to the therapy pads.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.The customer reported the device use did not impact patient care.

Event Description

The customer contacted physio-control to report that their device had an intermittent connection to the therapy pads.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.The customer reported the device use did not impact patient care.

Manufacturer Narrative

Physio-control received additional patient information from the customer.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.

Manufacturer Narrative

The root cause was determined to be due to use of third party therapy pads (veramed) from 2013.

Event Description

The customer contacted physio-control to report that their device had an intermittent connection to the therapy pads.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.The customer reported the device use did not impact patient care.

• 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
• 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: 12544525
• MDR Text Key: 273748359
• Report Number: 0003015876-2021-01850
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873912782
• UDI-Public: 00883873912782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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: 99577-001218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Date Manufacturer Received: 01/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Race: White