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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 Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2023
Event Type  malfunction  
Event Description
A customer contacted stryker to report that their device would not recognize the ecg rhythm when connected to a patient.As a result, defibrillation therapy would not be available, if needed.There were no reports of adverse effects to the patient as a result of the reported event.
 
Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Stryker will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Stryker performed an initial evaluation of the customer's device and was unable to duplicate the reported issue.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 that their device would not recognize the ecg rhythm when connected to a patient.As a result, defibrillation therapy would not be available, if needed.There were no reports of adverse effects to the patient as a result of the reported event.
 
Manufacturer Narrative
A customer quality engineer reviewed the electronic patient records and could not confirm the reported issue.The electrodes used during the reported event were not provided for testing.For other unrelated repairs, the customer declined the repairs and the device was returned to unrepaired, per request.A cause of the reported issue could not be determined.
 
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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 Key16374834
MDR Text Key309529651
Report Number0003015876-2023-00281
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K142430
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 05/03/2023
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 Number99577-000823
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2023
Initial Date Manufacturer Received 01/25/2023
Initial Date FDA Received02/14/2023
Supplement Dates Manufacturer Received04/25/2023
Supplement Dates FDA Received05/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2014
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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