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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 Known Impact Or Consequence To Patient (2692)
Event Date 12/21/2019
Event Type  malfunction  
Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient. The customer provided physio-control with all the available patient information. Patient fields in which information is not provided were intentionally left blank. 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
Third party service agent contacted physio-control to report that a customer¿s device failed to shock, as there was a minimal physical response following the defibrillator. The defibrillator was swapped with another, and the patient was able to be revived. A back up device was used to provide defibrillation. A third party evaluated the device and noted it delivered 0j when charged to 200j. This issue is patient related; however there was no adverse patient outcome reported.
 
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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 Key9597445
MDR Text Key189643861
Report Number0003015876-2020-00090
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001418
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/31/2014
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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