MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR2® DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number CR2

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problems Asthma (1726); Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.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 did not analyze correctly.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

Clinical signs code of the initial medwatch report indicated: asthma.Clinical signs code of the initial medwatch report should have indicated: cardiac arrest.

Event Description

The customer contacted physio-control to report that their device did not analyze correctly.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

Section h6, clinical signs code of mfr # 0003015876-2021-00601-001indicated "cardiac arrest".This code has been corrected to "no clinical signs, symptoms, or conditions." stryker evaluated the customer's device.The reported issue was unable to be duplicated.Evaluation of device files determined that rhythm is borderline and is not an indication of device malfunction.The shock advisory algorithm is a diagnostic test and diagnostic tests always have a level of accuracy that is less than 100%.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.No parts were replaced.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device did not analyze correctly.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.

• Brand Name: LIFEPAK CR2® DEFIBRILLATOR
• 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: 11521487
• MDR Text Key: 240981474
• Report Number: 0003015876-2021-00601
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P170018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-000118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 04/27/2021; 02/09/2022
• Supplement Dates FDA Received: 05/07/2021; 02/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male