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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 Problems Failure to Deliver Shock/Stimulation (1133); Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2022
Event Type  malfunction  
Manufacturer Narrative
A third party service agent performed an initial evaluation of the customer's device and observed that the device would not detect an ecg rhythm and would not provide shock.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
A customer contacted stryker to report a non critical issue with their device.Upon inspection, a third party service agent observed that the device would not detect an ecg rhythm and would not provide shock.As a result, defibrillation therapy would not be available, if needed.There was no patient use associated with the reported event.
 
Event Description
A customer contacted stryker to report a non critical issue with their device.Upon inspection, a third party service agent observed that the device would not detect an ecg rhythm and would not provide shock.As a result, defibrillation therapy would not be available, if needed.There was no patient use associated with the reported event.
 
Manufacturer Narrative
The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to stryker for evaluation.The reported issue could not be verified by stryker and the cause of the reported issue could not be determined.
 
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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
dara friedman
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key16544023
MDR Text Key311292311
Report Number0003015876-2023-00486
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeIR
PMA/PMN Number
P160026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20E
Device Catalogue Number99507-000095
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2023
Date Manufacturer Received05/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2021
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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