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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the device and verified the reported issue. However, the issue was not duplicated and further cause could not be determined. The device passed functional and performance testing and was returned to the customer.
 
Event Description
During evaluation for an unrelated issue, physio-control found an event code logged in the device's memory which indicates an occurrence of failure to deliver energy due to the charge function being disabled. As a result, the unit may not have been able to provide defibrillation therapy if it was necessary. There was no report of patient involvement associated to the 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
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 Key12558876
MDR Text Key274254402
Report Number0003015876-2021-01883
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001964
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2016
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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