MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20E

Device Problem Device Sensing Problem (2917)

Patient Problem Asystole (4442)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

The customer contacted stryker to report that during a patient event their device was unable to detect the patient through the defibrillation electrodes.The customer advised that the device prompted them to ¿connect electrodes¿ when the defibrillation electrodes were connected to the patient.The customer advised they were using third party conmed padpro defibrillation electrodes.The patient did not survive.The customer reported that it was considered likely that the patient was found in asystole, or expired, but the paramedics were performing required measures upon their delivery of the patient to the facility.

Manufacturer Narrative

The customer provided stryker with all the available patient information.Patient fields in which information was not provided were intentionally left blank.Stryker performed a clinical review of the reported issue and determined that the device use did not contribute to the patient outcome due to the following: the healthcare provider reported that the patient was in asystole or expired before the resuscitation began.In the medical judgment of these reviewers, the device did not cause or contribute to the reported outcome.Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Manufacturer Narrative

Stryker evaluated the customer's device and was able to verify the reported issue through the electronic records of device.However, the reported issue could not be duplicated.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 was unable to detect the patient through the defibrillation electrodes.The customer advised that the device prompted them to ¿connect electrodes¿ when the defibrillation electrodes were connected to the patient.The customer advised they were using third party conmed padpro defibrillation electrodes.The patient did not survive.The customer reported that it was considered likely that the patient was found in asystole, or expired, but the paramedics were performing required measures upon their delivery of the patient to the facility.

• Brand Name: LIFEPAK® 20E 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: 18335199
• MDR Text Key: 330787410
• Report Number: 0003015876-2023-02376
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873852804
• UDI-Public: 00883873852804
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: 20E
• Device Catalogue Number: 99507-000132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White