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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 1000
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 04/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was not returned to physio-control for evaluation. A third-party service agent evaluated the device and verified the reported issue. It was determined that the device was no longer under warranty and not field serviceable. The cause of the reported issue could not be determined.
 
Event Description
The customer sent their device to a third party service agent for the completion of a technical service update (tsu). There were no reports of patient use associated with the reported event or any issues with the device prior to being sent to the service agent. Upon evaluation of the customer¿s device, the third party service agent observed that the device would not complete the boot-up cycle in order to power on, despite showing ¿ok¿ on its readiness display.
 
Event Description
The customer sent their device to a third party service agent for the completion of a technical service update (tsu). There were no reports of patient use associated with the reported event or any issues with the device prior to being sent to the service agent. Upon evaluation of the customer¿s device, the third party service agent observed that the device would not complete the boot-up cycle in order to power on, despite showing ¿ok¿ on its readiness display.
 
Manufacturer Narrative
The customer agreed to ship the device to physio-control for further root cause analysis. Physio-control evaluated the customer's device and verified the reported issue. The cause of the reported issue was determined to be due to a failure of the digital pcb assembly.
 
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Brand NameLIFEPAK(R) 1000 DEFIBRILLATOR
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key7659719
MDR Text Key113266889
Report Number0003015876-2018-01037
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K122600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000
Device Catalogue Number99425-000097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2018
Is This a Reprocessed and Reused Single-Use Device? No

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