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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 1000 DEFIBRILLATOR; AUTOMATIC EXTERNAL DEFIBRILLATOR

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 1000 DEFIBRILLATOR; AUTOMATIC EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 1000
Medical Device Problem Code Device Sensing Problem (2917)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/02/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A stryker customer service specialist informed the customer that due to the age of the device, the device cannot be serviced, and recommended the device be taken out of service.The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.
 
Event or Problem Description
The customer contacted stryker to report that their device continuously gives the "connect electrodes" message when attached to a patient.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
 
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Brand Name
LIFEPAK 1000 DEFIBRILLATOR
Common Device Name
AUTOMATIC EXTERNAL DEFIBRILLATOR
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 Key24190837
Report Number0003015876-2026-00200
Device Sequence Number9600763
Product Code MKJ
UDI-Device Identifier00883873815458
UDI-Public00883873815458
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K122600
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source User Facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/27/2026
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
Operator of Device Health Professional
Device Model Number1000
Device Catalogue Number99425-000023
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/02/2026
Initial Report FDA Received Date01/27/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured07/29/2008
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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