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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 Device Sensing Problem (2917)
Patient Problem Asystole (4442)
Event Date 11/08/2022
Event Type  malfunction  
Event Description
The customer contacted stryker to report that during a patient event their device was unable to detect the defibrillation electrodes connected to the patient.The customer advised that the device "stated that no paddles were detected".In this state defibrillation therapy would be delayed or unavailable if needed.This issue is patient related; however the customer advised that there was no adverse outcome occurred.
 
Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer informed stryker that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.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 during a patient event their device was unable to detect the defibrillation electrodes connected to the patient.The customer advised that the device "stated that no paddles were detected".In this state defibrillation therapy would be delayed or unavailable if needed.This issue is patient related; however the customer advised that there was no adverse outcome occurred.
 
Manufacturer Narrative
Stryker evaluated the customer¿s device but was unable to verify or duplicate the reported issue.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.
 
Manufacturer Narrative
Stryker evaluated the customer¿s device but was unable to verify or duplicate the reported issue.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.
 
Event Description
The customer contacted stryker to report that during a patient event their device was unable to detect the defibrillation electrodes connected to the patient.The customer advised that the device "stated that no paddles were detected".In this state defibrillation therapy would be delayed or unavailable if needed.This issue is patient related; however the customer advised that there was no adverse outcome occurred.
 
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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
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key15788873
MDR Text Key303575010
Report Number0003015876-2022-02505
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142430
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,Followup
Report Date 03/13/2023
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 Number99577-001255
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 11/08/2022
Initial Date FDA Received11/14/2022
Supplement Dates Manufacturer Received03/09/2023
03/09/2023
Supplement Dates FDA Received03/13/2023
03/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2015
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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