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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 Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue. Physio found broken pieces of the device's therapy pcb assembly inside the bottom case, damage to the j2 capacitor connector, and damage to the front and top cases. The therapy pcb assembly, capacitor connector, front and top cases were replaced to resolve the reported issue. After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
 
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 by physio-control it was found that the device logged a critical event code. The event code 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.
 
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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 Key10715051
MDR Text Key212467714
Report Number0003015876-2020-01560
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,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number99402-000001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2005
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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