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

Model Number 20E

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Death (1802)

Event Date 11/26/2019

Event Type  Death  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient. No response has been received from the customer. Patient fields in which information is not provided were intentionally left blank. Physio-control performed and initial evaluation of the customers device and was unable to duplicate the reported issue. Physio performed a clinical review of the device data and determined device use caused the reported death stating, the patient was in a viable state with organized ecg rhythm or other evidence of viability (e. G. , vital signs, level of consciousness), and the malfunction/use error placed the patient in a life-threatening condition. The code-stat file retrieved from the device contained a 1 hour, 52 minute, and 20 second case. The patient presented in atrial fibrillation with a variable heart rate ranging from 60 beats per minute to 70 beats per minute from the time of leads on at 10:27:28 am to 11:31:31 am. At 11:31:31 am the patient was defibrillated at 200 joules (j) converting them into ventricular fibrillation (vf). The patient remained in vf throughout the remainder of the case, receiving an additional 15 200 j shocks. The clinical review also noted one use error stating, the user defibrillated an organized rhythm converting the patient into vf. Per the lp20e operating instructions, page ix: indications defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia and, in relatively stable patients, ventricular tachycardia. Note: the lifepak 20e defibrillator/monitor comes configured with an escalating energy protocol (200 j, 300 j, 360 j). Energy escalation up to 360 j is recommended for difficult to defibrillate patients. Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56.

Event Description

The customer contacted physio-control to report that their device failed to bring the patient out of v-fib when attempting defibrillation. The customer indicated that device use may have contributed to patient death.

• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 9538541
• MDR Text Key: 173316321
• Report Number: 0003015876-2020-00006
• Device Sequence Number: 1
• Product Code: MKJ
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 20E
• Device Catalogue Number: 99507-000133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 01/02/2020 Patient Sequence Number: 1