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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 Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Date 09/11/2019
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the device had logged an event code into its memory. The customer was provided with a replacement device. Physio-control further evaluated the device and observed that the device was slow to charge and the delivered energy was lower than expected. The cause of the reported issue was determined to be due to a damaged component, designator u1, on the analog pcb assembly.
 
Event Description
The customer contacted physio-control to report that their device had logged an event code into its memory. Upon further evaluation, physio-control observed that the device was slow to charge and the delivered energy was lower than expected. In this state, wrong defibrillation therapy may be provided, if it were needed. There was no patient use associated with the reported event.
 
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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
Manufacturer (Section G)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer Contact
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key9672077
MDR Text Key190778199
Report Number0003015876-2020-00165
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K122600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000
Device Catalogue Number99425-000199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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