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U.S. Department of Health and Human Services

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

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Date 08/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Physio-control evaluated the customer's device and verified that the event code was logged in the device's memory; however, the issue could not be duplicated during testing. Physio then cleared the device's memory, which cleared the event code, and completed other unrelated repairs. After observing proper device operation through functional and performance testing the unit was returned to the customer for use. The cause of the reported issue could not be determined.
 
Event Description
The customer contacted physio-control to report a non-critical issue with their device. There was no report of patient use associated with the reported event. Upon evaluation of the customer's device, physio-control observed an event code logged in the device's memory that is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock. As a result, the wrong defibrillation therapy may be delivered to a patient, if it was needed.
 
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Brand NameLIFEPAK® 15 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 Key8950279
MDR Text Key156123672
Report Number0003015876-2019-01454
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 08/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001955
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2015
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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