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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and the reported issue was verified and duplicated.Physio replaced the system controller pcb assembly and the user interface (ui) pcb assembly, which resolved the reported issue.Other unrelated repairs were completed and proper device operation was observed through functional and performance testing.The device was returned to the customer for use.
 
Event Description
The customer contacted physio-control to report that their device would not complete the boot-up process and the device would lock up.As a result, the need for therapy and/or ability to provide therapy could have been delayed or prevented, if it had been necessary.There was no patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control further evaluated the removed system controller pcb assembly and verified the reported issue.However after further testing the reported issue could not be duplicated.The removed user interface pcb assembly was an ancillary part and there was no failure of this assembly.
 
Event Description
The customer contacted physio-control to report that their device would not complete the boot-up process and the device would lock up.As a result, the need for therapy and/or ability to provide therapy could have been delayed or prevented, if it had been necessary.There was no patient use associated with the reported event.
 
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Brand Name
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
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
meg marseglia
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key7606383
MDR Text Key111456555
Report Number0003015876-2018-00942
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 company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received07/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2004
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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