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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 Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Date 09/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Physio-control performed an initial evaluation of the customer's device and verified the reported issue. Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56.
 
Event Description
The customer contacted physio-control to report a non-critical issue with their device. There was no patient use associated with the reported event. Upon evaluation of the customer's device, physio-control observed that the device delivered a monophasic shock at 23. 4 joules at a selected energy level of 200 joules. As a result, the wrong defibrillation therapy may be delivered to a patient, if it is 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
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key9211601
MDR Text Key190687825
Report Number0003015876-2019-01709
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2019
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 Manufacturer09/19/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2003
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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