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

Model Number 15

Device Problem Failure to Analyze Signal (1539)

Patient Problem Respiratory Failure (2484)

Event Date 04/05/2021

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 is not provided were intentionally left blank.Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the therapy connector of the device and then observed proper device operation through functional and performance testing.The device was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device paddles lead ecg displayed severe artifact.In this state, the device may not have the ability to function in aed mode, and defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.The customer did advise that ecg was obtained through the patient ecg cable.The patient was unconscious and not breathing, resuscitation was done at the scene, but no return of spontaneous breathing or heartbeat.The patient did not survive, however the customer a health care provider confirmed that the device use did not contribute to the patient outcome.The patient did not require defibrillation.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 11764163
• MDR Text Key: 248668911
• Report Number: 0003015876-2021-00979
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873884331
• UDI-Public: 00883873884331
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• 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: 99577-001373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2011
• 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: 69 YR
• Patient Weight: 45