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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR® PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR® PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE Back to Search Results
Model Number CR PLUS
Medical Device Problem Code Failure to Power Up (1476)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/27/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was not returned to physio-control for evaluation.The reported issue could not be verified and root cause could not be determined.Device not returned for evaluation.
 
Event or Problem Description
The customer contacted physio-control to report that their device was not always turning on when the cover was opened.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient use associated with the reported event.
 
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Brand Name
LIFEPAK CR® PLUS DEFIBRILLATOR
Common Device Name
AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key9512170
Report Number0003015876-2019-02050
Device Sequence Number18929622
Product Code MKJ
UDI-Device Identifier00883873823927
UDI-Public00883873823927
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K033275
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/23/2019
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
Operator of Device Lay User/Patient
Device Model NumberCR PLUS
Device Catalogue Number99403-000001
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/27/2019
Initial Report FDA Received Date12/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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