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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/18/2018
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 as provided by 21 cfr 803. 56.
 
Event Description
The customer, a biomedical engineer, contacted physio-control to report that when attempting to start the user test, the device would power itself off and reboot. There was no patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue. Physio replaced the device's user interface pcb and system controller pcb assemblies. After observing proper device operation through functional and performance testing, the device was returned to the customer for use. Physio-control further evaluated the removed user interface pcb assembly and did not observe any issues with this part. Physio also further evaluated the removed system controller pcb assembly and was unable to duplicate the reported issue while testing this part. A further component root cause for the reported issue could not be determined. It was later confirmed that the reported device is an acls trainer which is labeled as not for clinical use.
 
Event Description
The customer, a biomedical engineer, contacted physio-control to report that when attempting to start the user test, the device would power itself off and reboot. There was no patient use associated with the reported event.
 
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Brand NameLIFEPAK® 20 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 Key7593834
MDR Text Key110847591
Report Number0003015876-2018-00923
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number96402-000007
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

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