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

Model Number 1000

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

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

Event Date 06/12/2020

Event Type  Death  

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

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 established performance of the lifepak shock advisory algorithm is based on testing with large data sets.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.

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 lp20 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 analyses 1,3, and 4, the decision was no shock advised because the rhythm was pulseless vt.There was significant flat content.During analysis 2, the rhythm had alternated and degraded into vf.Analysis 5 data was unable to be recovered in the pco file.There was no device malfunction.The sas 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 # 99402-000039 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) 20 defibrillator/monitor.

Manufacturer Narrative

Section b5 of supplemental medwatch report 0003015876-2021-00851 indicates: 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.Section b5 of supplemental medwatch report 0003015876-2021-00851 should indicate: the customer contacted stryker to inform that their device would not detect a shockable rhythm during the patient event.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.

• Brand Name: LIFEPAK(R) 20 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: 11682442
• MDR Text Key: 245925373
• Report Number: 0003015876-2021-00851
• 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,Followup
• Report Date: 10/07/2021

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
• Device Operator: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 99425-000199
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 06/14/2021; 08/31/2021; 10/04/2021
• Supplement Dates FDA Received: 07/12/2021; 09/23/2021; 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Weight: 105