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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 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was not returned to physio-control for evaluation. A third-party service agent performed an initial evaluation of the device and was unable to reproduce the reported issue. Physio 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
The customer contacted physio-control to report that their device locked up during the power on sequence. In this state the device would not be able to charge and shock defibrillation energy, when needed. There was no patient use associated with the reported event.
 
Manufacturer Narrative
The third party service agent was able to confirm the reported issue. The cause of the reported issue was determined to be due to a failure of the system pcb assembly. The service agent repaired the device by replacing the system pcb assembly. Other unrelated repairs were also completed. Proper device operation was observed through functional and performance testing and the device was returned to the customer for use. The customer's device nor the system pcb assembly were returned to physio-control for an evaluation.
 
Event Description
The customer contacted physio-control to report that their device locked up during the power on sequence. In this state the device would not be able to charge and shock defibrillation energy, when needed. There was no patient use associated with the reported event.
 
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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
MDR Report Key7612699
MDR Text Key111861294
Report Number0003015876-2018-00959
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,Followup
Report Date 02/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-000057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

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