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

Model Number 20E

Device Problems Loss of Power (1475); Incorrect Interpretation of Signal (1543)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer in order to obtain additional information about the patient and event; however, no response was received.Physio-control 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.

Event Description

The customer contacted stryker to inform that their device would not detect a shockable rhythm during the patient event.It was also reported that their device had experienced an unexpected loss of power.The customer advised that the patient did not survive the event.

Event Description

The customer contacted stryker to inform that their device would not detect a shockable rhythm during the patient event.It was also reported that their device had experienced an unexpected loss of power.The customer advised that the patient did not survive the event.

Manufacturer Narrative

Physio-control received additional patient information from the customer.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.   physio control reviewed electronic patient records and the customer quality engineer performed scientific analysis.The lp20e shock advisory algorithm measures various characteristics of an ecg to determine if a rhythm is shockable or nonshockable.These characteristics include flat content, amplitude, rate, and steepness of the slopes of the ecg.Each measurement has a corresponding threshold that demarcates shockable and nonshockable rhythms.The algorithm makes these measurements for an approximately 3-second long segment of ecg and determines if the segment is shockable or nonshockable.The algorithm repeats the process with a second segment.If the decisions from the analyses of the 1st and 2nd segments do not agree a third segment is analyzed to break the tie.A 2-out-of-3 voting scheme is used to determine the final ¿shock advised¿ or ¿no shock advised¿ decision.In analysis 1, 3, 5, and 7, the rhythm displayed a slower rate.This is not indicative of pulseless vt/vf.Specifically in analysis 1, there was too much flat content, which indicates the rhythm was not a shockable one.The analyses 2,4,and 6 were ¿shock advised¿ decisions.The rhythm can clearly be seen to alternate between vt and vf.There was no device malfunction.The sas (shock advisory system) algorithm performed as intended.Section d4 of the initial medwatch report indicates: catalog # 99425-000199.Section d4 of the initial medwatch report should indicate: catalog # 99507-000050.Section d1 of the initial medwatch report indicates: product long description - lifepak(r) 1000 defibrillator.Section d1 of the initial medwatch report should indicate: product long description lifepak(r) 20e defibrillator/monitor.

Event Description

The customer contacted stryker to inform that their device would not detect a shockable rhythm during the patient event.It was also reported that their device had experienced an unexpected loss of power.The customer advised that the patient did not survive the event.

Manufacturer Narrative

There was no device malfunction and it operated as designed.The root cause of the device not shocking on the first attempt is because the sas (shock advisory system) algorithm evaluated the patient rhythm to be 'no shock advised'.The recommendations of the device do not indicate a device malfunction.This is because the shock advisory algorithm is a diagnostic test and diagnostic tests always have a level of accuracy that is less than 100% (i.E., no test is perfect).There is an acceptable level of sensitivity and specificity as set by international standards for aed performance.The sensitivity requirement of rapid vt is 75%.The established performance of the lifepak shock advisory algorithm is based on testing with large data sets and exceeds these standards.Although the shock advisory algorithm has high sensitivity for vf, occasionally, the patient¿s ecg rhythm falls outside of the algorithm¿s ability to determine a ¿shock advised¿ decision due to the measurements falling near the threshold between a shockable and nonshockable rhythm.Sensitivity for coarse ventricular fibrillation is 99% and specificity for non-shockable rhythm detection is 98%2.The algorithm decisions in this casefile are not indicative of algorithm deviation from its established sensitivity and specificity as the ecg threshold criteria of a ¿shock advised¿ or ¿no shock advised¿ decision was met for each analysis.No evidence of device malfunction was observed during this analysis.Reference appendix e of the lp20e operating instructions for more information on shock advisory system.

• Brand Name: LIFEPAK(R) 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
• MDR Report Key: 11682440
• MDR Text Key: 245925381
• Report Number: 0003015876-2021-00849
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20E
• Device Catalogue Number: 99425-000199
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 71