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U.S. Department of Health and Human Services

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

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20E DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
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.
 
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Brand NameLIFEPAK® 20E DEFIBRILLATOR/MONITOR
Type of DeviceAUTOMATED 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 Key9538541
MDR Text Key173316321
Report Number0003015876-2020-00006
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160026
Number of Events Reported1
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 Received01/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number20E
Device Catalogue Number99507-000133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2018
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
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