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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue. Physio-control also observed that the device was delivering monophasic energy rather than biphasic energy. The energy delivered by the device was also at a lower energy level than what was selected. 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 found that a service indicator is present and an event code is logged in the memory of their device. The event code logged in its memory 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. Additionally, the defibrillator output energy may be reduced by up to approximately 20% from the selected energy level. As a result, the wrong defibrillation therapy would be delivered, if it were necessary.
 
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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 Key10770000
MDR Text Key214110362
Report Number0003015876-2020-01616
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 01/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001256
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2014
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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