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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 06/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Physio-control evaluated the customer¿s device and verified the reported issue. It was also observed that one side of the power button was difficult to activate. Physio replaced the device's main keypad assembly. The battery pins were also replaced as a preventative measure. After other unrelated repairs were completed, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.
 
Event Description
The customer contacted physio-control to report that intermittently their device would have a blank display and the service indicator would be illuminated. In this state defibrillation therapy may not be available to a patient if needed. There was no patient use reported for this event. Upon evaluation of the customer¿s device, physio-control observed that the device was unable to complete a boot cycle and had a blank display.
 
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Brand NameLIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
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 Key7661152
MDR Text Key113328410
Report Number0003015876-2018-01048
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
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 Number15
Device Catalogue Number99577-000043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
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? Yes
Date Device Manufactured07/30/2010
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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