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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 Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and verified the reported issue.Physio replaced the system pcb assembly.Thereafter, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.
 
Event Description
The customer contacted physio-control to report that when attempting to power on their device it locked up at the self-test screen and would not complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control further evaluated the removed system pcb assembly and determined that the cause of the reported issue was that the single board computer (sbc) portion of the assembly was inoperative.
 
Event Description
The customer contacted physio-control to report that when attempting to power on their device it locked up at the self-test screen and would not complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
 
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Brand Name
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key7583320
MDR Text Key110530194
Report Number0003015876-2018-00896
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 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-000155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2018
Date Manufacturer Received09/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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