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

Model Number	20E
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0003015876-2023-02376
• Device Sequence Number: 20518187
• Product Code: MKJ
• UDI-Device Identifier: 00883873852804
• UDI-Public: 00883873852804
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White