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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR(R) PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR(R) PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number CRPLUS
Device Problems Failure to Sense (1559); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2023
Event Type  malfunction  
Manufacturer Narrative
A third-party service agent performed an initial evaluation of the customer¿s device and was able to verify the reported issue.The electrodes sent for the evaluation are not approved and it's indicated that they may not be the ones used on the patient.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
 
Event Description
A customer contacted stryker to report that their device did not detect rhythm and unexpectedly lost power.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
 
Manufacturer Narrative
Results code grid of initial mdr indicates: electrical/electronic component problem identified.Results code grid of initial mdr should indicate: operational problem identified.Conclusion code grid of initial mdr indicates: cause traced to component failure.Conclusion code grid of initial mdr should indicate: cause not established.A cause of the reported issue could not be determined.
 
Event Description
A customer contacted stryker to report that their device did not detect rhythm and unexpectedly lost power.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
 
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Brand Name
LIFEPAK CR(R) PLUS 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 Key16311559
MDR Text Key308974841
Report Number0003015876-2023-00192
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K033275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/16/2023
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 NumberCRPLUS
Device Catalogue Number99403-000041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2023
Initial Date Manufacturer Received 01/11/2023
Initial Date FDA Received02/07/2023
Supplement Dates Manufacturer Received05/10/2023
Supplement Dates FDA Received05/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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