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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
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 03/01/2021
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 lp1000 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.The file contained five sas analyses.In analysis 1-3, there was ¿no shock advised¿.In analysis 4 & 5, it was ¿shock advised¿.In analysis 1-3, the ecg rhythm had significant steep positive slope segments.This is indicative of perfusing vt.The patient rhythm had changed in analysis 4 & 5.It had characteristics of distinctive ventricular fibrillation.As such, the algorithm advised a ¿shock¿ decision.There was no device malfunction.The sas algorithm performed as intended.
 
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 and exceeds these standards.A single case such as this one does not provide evidence that the algorithm no longer meets performance standards.
 
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Brand Name
LIFEPAK(R) 1000 DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key11682445
MDR Text Key245925467
Report Number0003015876-2021-00848
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
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 Received04/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1000
Device Catalogue Number99425-000199
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age82 YR
Patient Weight85
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