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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Ventricular Fibrillation (2130)
Event Date 09/18/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56.
 
Event Description
A customer contacted physio-control to report that their device was used to provide a synchronized shock to a patient during a cardioversion procedure. After the delivery of the synchronized shock, the patient's rhythm converted from stable ventricular tachycardia to ventricular fibrillation. The customer advised that the sense markers did not appear regularly on each qrs complex, and medical personnel were concerned that the patient had received a shock on the t-wave. Physio-control contacted the customer in order to obtain additional information about the patient, including the patient outcome; however, no response has been received.
 
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Brand NameLIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
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 Key9234673
MDR Text Key163640120
Report Number0003015876-2019-01743
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-000657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2012
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: 10/24/2019 Patient Sequence Number: 1
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