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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK COMBO; ELECTRODE, ELECTROCARDIOGRAPH
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PHYSIO-CONTROL, INC. - 3015876 QUIK COMBO; ELECTRODE, ELECTROCARDIOGRAPH Back to Search Results
Model Number 11996
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Event Description
The customer contacted stryker to report that they were using their device on a patient and the defibrillation electrodes failed to pick up the patient's ecg rhythm.As a result, defibrillation therapy may have been delayed or unavailable, if needed.A new set of defibrillation electrodes were used to continue patient care.There were no reports of any adverse effects to the patient as a result of the reported issue.
 
Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Neither the device nor the electrodes were returned to stryker for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
 
Event Description
The customer contacted stryker to report that they were using their device on a patient and the defibrillation electrodes failed to pick up the patient's ecg rhythm.As a result, defibrillation therapy may have been delayed or unavailable, if needed.A new set of defibrillation electrodes were used to continue patient care.There were no reports of any adverse effects to the patient as a result of the reported issue.
 
Manufacturer Narrative
Stryker evaluated the defibrillation electrodes that were used during the event and was unable to duplicate the reported issue.The defibrillation electrodes were archived by stryker.The cause of the reported issue could not be determined.
 
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Brand Name
QUIK COMBO
Type of Device
ELECTRODE, ELECTROCARDIOGRAPH
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 Key13022799
MDR Text Key282390697
Report Number0003015876-2021-02373
Device Sequence Number1
Product Code DRX
UDI-Device Identifier00883873784969
UDI-Public00883873784969
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K943301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/15/2023
Device Model Number11996
Device Catalogue Number11996-000017
Device Lot Number111994
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
LIFEPAK® 15 DEFIBRILLATOR/MONITOR, MKJ
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