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

Model Number	20E
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/09/2023
Type of Reportable Event	Death
Event or Problem Description
Stryker was notified that the customer submitted a voluntary medwatch (medsun) form.Medwatch reference report number is unknown.The following was reported by the customer: "the patient went into cardiopulmonary arrest on (b)(6) 2023 at approx.19:00.Cpr was initiated and the lifepak 20e defibrillator was attached.He was found to be in pulseless / vf.There was an unforeseeable malfunctioning with the patient's bedside lifepak 20e which resulted in no defibrillation being received.Despite the lifepak 20e appearing functional and showing the dysrhythmia, it did not discharge.Ultimately, patient missed the first two required defibrillations in accordance with acls protocol due to this malfunctioning.A new lifepak 20e was obtained, and patient's first defibrillation was recorded at 19:12.Patient received maximal therapy including multiple defibrillations and other medications.While arranging transfer to icu, patient again went into pulseless vt.Acls protocol was resumed.Family wished to cease resuscitative efforts.Patient death pronounced at 19:43.".
Additional Manufacturer Narrative
The customer provided stryker with all the available patient information.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 unable to verify or duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Stryker downloaded and reviewed the electronic records from the device and observed that the charge button was pressed on 2 occasions but the shock button was never pressed.Stryker determined that the cause of the reported issue was due to be user error.
Event or Problem Description
Stryker was notified that the customer submitted a voluntary medwatch (medsun) form.Medwatch reference report number is unknown.The following was reported by the customer: "the patient went into cardiopulmonary arrest on (b)(6) 2023 at approx.19:00.Cpr was initiated and the lifepak 20e defibrillator was attached.He was found to be in pulseless/vf.There was an unforeseeable malfunctioning with the patient's bedside lifepak 20e which resulted in no defibrillation being received.Despite the lifepak 20e appearing functional and showing the dysrhythmia, it did not discharge.Ultimately, patient missed the first two required defibrillations in accordance with acls protocol due to this malfunctioning.A new lifepak 20e was obtained, and patient's first defibrillation was recorded at 19:12.Patient received maximal therapy including multiple defibrillations and other medications.While arranging transfer to icu, patient again went into pulseless vt.Acls protocol was resumed.Family wished to cease resuscitative efforts.Patient death pronounced at 19:43.".
Additional Manufacturer Narrative
Stryker performed a clinical review of the reported event and determined that it was unknown if the device use contributed to the patient outcome for the following reason: "insufficient data within the file to determine the impact of the device use.There was inadequate contextual information from the patient¿s data file to identify the appropriate patient¿s event.The shock button was pressed per the customer information provided, but no shock was delivered.Because the ecg was unavailable, it is unknown if the patient was in a shockable rhythm at the time of the event or if energy was delivered.
Event or Problem Description
Stryker was notified that the customer submitted a voluntary medwatch (medsun) form.Medwatch reference report number is unknown.The following was reported by the customer: "the patient went into cardiopulmonary arrest on (b)(6) 2023 at approx.19:00.Cpr was initiated and the lifepak 20e defibrillator was attached.He was found to be in pulseless/vf.There was an unforeseeable malfunctioning with the patient's bedside lifepak 20e which resulted in no defibrillation being received.Despite the lifepak 20e appearing functional and showing the dysrhythmia, it did not discharge.Ultimately, patient missed the first two required defibrillations in accordance with acls protocol due to this malfunctioning.A new lifepak 20e was obtained, and patient's first defibrillation was recorded at 19:12.Patient received maximal therapy including multiple defibrillations and other medications.While arranging transfer to icu, patient again went into pulseless vt.Acls protocol was resumed.Family wished to cease resuscitative efforts.Patient death pronounced at 19:43.".

• Brand Name: LIFEPAK(R) 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17656771
• Report Number: 0003015876-2023-01564
• Device Sequence Number: 6190683
• Product Code: MKJ
• UDI-Device Identifier: 00883873853863
• UDI-Public: 00883873853863
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20E
• Device Catalogue Number: 99507-000122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/21/2023; 10/20/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/17/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2017
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White