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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 Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda. Device not evaluated by manufacturer.
 
Event Description
A third party biomedical engineer contacted physio-control to report that a customer's device will not complete the boot-up process and the service light is illuminated. There was no patient use associated with the reported event.
 
Manufacturer Narrative
This report is a duplicate of a medwatch report that was already submitted. Please refer to mfg report # 0003015876-2018-01723 and follow up report # 0003015876-2018-01723-001. Physio-control evaluated the customer¿s device and verified the reported issue. Physio replaced the system pcb assembly to resolve the reported issue. Proper device operation was observed through functional and performance testing. The device was returned to the customer for use. Physio-control further evaluated the removed system pcb assembly and determined that the cause of the reported issue was the single board computer (sbc) located on the assembly. The sbc was inoperative, which prevented the device from completing the boot-up process.
 
Event Description
A third party biomedical engineer contacted physio-control to report that a customer's device will not complete the boot-up process and the service light is illuminated. There was no patient use associated with the reported event.
 
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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
MDR Report Key7597537
MDR Text Key110962468
Report Number0003015876-2018-00928
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 health professional
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-000006
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Is This a Reprocessed and Reused Single-Use Device? No

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