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U.S. Department of Health and Human Services

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

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Physio-control evaluated the customer device's and verified the reported issue. Physio replaced the device's system controller and user interface pcb assemblies to resolve the reported issue. After observing proper device operation through functional and performance testing, the device was returned to the customer for use. Physio-control further evaluated the removed user interface pcb assembly. No issue was found with this component. Physio-control further evaluated the removed system controller pcb assembly and observed that it was causing the test device to intermittently boot up with a white display. When this occurred, the device was inoperable. A further root cause for the boot-up issue could not be conclusively determined.
 
Event Description
The customer contacted physio-control to report that the service indicator is present and an event code is logged in the memory of their device. There was no patient use associated with the reported event. After evaluating and repairing the customer's device, one of the removed components was further evaluated by physio-control and it was observed that it would intermittently cause the test device to boot up with a white display and no functions would be available. As a result, defibrillation therapy would not be available, if it was needed.
 
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Brand NameLIFEPAK® 20 DEFIBRILLATOR/MONITOR
Type of DeviceAUTOMATED 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
megan marseglia
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key7639458
MDR Text Key112450261
Report Number0003015876-2018-01021
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number99402-000016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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