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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20E
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2023
Event Type  malfunction  
Event Description
The customer contacted stryker to report that their device failed to recognize therapy cable.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
 
Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and was able to verify the reported issue.After replacing therapy connector and completing some unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
 
Event Description
The customer contacted stryker to report that their device failed to recognize therapy cable.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
 
Manufacturer Narrative
Stryker further evaluated the replaced part at the product assessment center (pac) and no discrepancies/malfunctions were observed during extensive functional testing.Lp20e benchtop was capable of recognizing a shockable vfib rhythm and was able to provide defibrillation therapy on all energy levels with no discrepancies.Root cause of the reported issue could not be established, reported issue could not be duplicated.The part is archived by stryker.
 
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Brand Name
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
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
brian blakeslee
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key18795653
MDR Text Key336421451
Report Number0003015876-2024-00452
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K130454
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 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20E
Device Catalogue Number99507-000097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2023
Date Manufacturer Received07/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2016
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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