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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 Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Date 07/12/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Physio-control evaluated the customer¿s device and verified the reported issue. Physio replaced the therapy pcb assembly. 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. Physio further evaluated the removed therapy pcb assembly. It was determined that the cause of the reported issue was due to an electrically shorted diode, designator cr30. Legs 5 and 9 of cr30 were electrically shorted.
 
Event Description
The customer contacted physio-control to report a non-critical issue with their device. Upon evaluation of the customer¿s device, physio-control observed that the device logged an event code that is indicative of a device issue that could result in a partial loss of defibrillator output energy due to a loss of the negative or positive portion of the biphasic output waveform. The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level. It was also observed that the device displayed "abnormal energy delivery¿ when attempting to defibrillate and that the energy output was a monophasic shock. There was no patient use associated with the reported event.
 
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Brand NameLIFEPAK(R) 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 Key8965674
MDR Text Key156627900
Report Number0003015876-2019-01491
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
Report Date 09/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number99402-000033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2005
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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