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U.S. Department of Health and Human Services

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

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20E DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20E
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 06/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The third party service agent evaluated the customer's device and verified the reported issue. The third party service agent determined the cause of the reported issue was due to the user interface pcb assembly. The device was not returned to physio-control for an evaluation. The cause of the reported issue could not be determined.
 
Event Description
A third party service agent contacted physio-control to report that when attempting to power on a customer's device, a white screen is displayed. A white screen is indicative of a device locking up and as a result, defibrillation may not be possible, if it were necessary. There was no patient use associated with the reported event.
 
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Brand NameLIFEPAK® 20E 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 Key7660185
MDR Text Key113267097
Report Number0003015876-2018-01044
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 07/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20E
Device Catalogue Number70507-000330
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/28/2018
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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