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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 Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2023
Event Type  malfunction  
Event Description
A customer contacted stryker to report that their device would not recognize the paddles.As a result, defibrillation would not be available, if needed.There was no patient use associated with the reported event.
 
Manufacturer Narrative
Stryker evaluated the customer¿s device and was not able to verify the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Root cause was not able to be established.
 
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Brand Name
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
Type of Device
AUTOMATED 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
dara friedman
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key18371386
MDR Text Key331086669
Report Number0003015876-2023-02445
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-001765
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2023
Date Manufacturer Received12/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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