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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 Patient Involvement (2645)
Event Date 11/14/2019
Event Type  malfunction  
Manufacturer Narrative
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 that their device delivers shocks that are too high.In this state an inappropriate shock may be delivered if needed.There was no patient use reported with the event.
 
Manufacturer Narrative
Physio-control evaluated the customer¿s device and verified the reported issue.The customer has declined quotation for further evaluation and repair.The device was returned to the customer unrepaired.
 
Event Description
The customer contacted physio-control to report that their device delivers shocks that are too high.In this state an inappropriate shock may be delivered if needed.There was no patient use reported with the event.
 
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Brand Name
LIFEPAK 15 DEFIBRILLATOR/MONITOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key9417694
MDR Text Key172625771
Report Number0003015876-2019-01955
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-000678
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2020
Date Manufacturer Received07/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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