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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 Ventricular Fibrillation (2130)
Event Date 07/28/2020
Event Type  Injury  
Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient. No response has been received from the customer. Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council. Physio-control evaluated the customer's device and was unable to duplicate the reported issue. After observing proper device operation through functional and performance testing, the device was subsequently returned to the customer for use. A physio clinical specialist performed a clinical review and determined that the device use contributed to the patient outcome due to user error.
 
Event Description
A customer contacted physio-control to report that they provided an unintentional shock to a patient instead of a synchronized (sync) shock, which converted the patient's heart rhythm into ventricular fibrillation. As a result, wrong defibrillation therapy was provided. The customer advised that a subsequent shock was provided, and converted the patient back to a normal sinus rhythm.
 
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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 Key10428701
MDR Text Key203717543
Report Number0003015876-2020-01098
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number99402-000010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/19/2020 Patient Sequence Number: 1
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