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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 Key or Button Unresponsive/not Working (4063)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2024
Event Type  malfunction  
Manufacturer Narrative
Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
The customer contacted stryker to report that their device was unable to enter manual mode by pressing one of the energy select buttons.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use associated with this event.
 
Event Description
The customer contacted stryker to report that their device was unable to enter manual mode by pressing one of the energy select buttons.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use associated with this event.
 
Manufacturer Narrative
Stryker evaluated the customer¿s device but was unable to duplicate or verify the reported issue.Device software was reloaded, and then after observing proper device operation through functional and performance testing the device was returned to the customer for use.The cause of the reported issue could not be determined.
 
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Brand Name
LIFEPAK® 15 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 Key19142667
MDR Text Key341130177
Report Number0003015876-2024-01014
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-002178
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2024
Supplement Dates Manufacturer Received08/16/2024
Supplement Dates FDA Received08/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2023
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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