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 Diaphoresis (2452)

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with all the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker evaluated the customer's device and was unable to duplicate the reported issue.The defibrillation electrodes used on the event was not available for return for evaluation.After observing proper device operation 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 stryker to report that during a patient event their device lost connection through the paddles lead.The duration of the lost connection was 15 seconds.The customer observed there was some "poor adherence of the pads".In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however, there was no adverse patient outcome reported.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18702276
• MDR Text Key: 335351709
• Report Number: 0003015876-2024-00330
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/14/2024

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
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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
• Treatment: QC ELECTRODES
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 63 KG