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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 04/28/2023
Event Type  malfunction  
Event Description
A customer contacted stryker to report that the electrodes of their device would not detect the patient when attached.This resulted in a delay in intervention for 20 minutes and defibrillation would not be available, when 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.Patient fields in which information is not provided were intentionally left blank.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 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 the electrodes of their device would not detect the patient when attached.This resulted in a delay in intervention for 20 minutes and defibrillation would not be available, when needed.There were no reports of adverse effects to the patient as a result of the reported event.
 
Manufacturer Narrative
The electrodes were returned to stryker for evaluation.The reported issue could not be duplicated or verified.A cause of the reported issue could not be determined.The electrodes were archived by stryker.
 
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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
dara friedman
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key17001078
MDR Text Key315908418
Report Number0003015876-2023-00953
Device Sequence Number1
Product Code DRX
UDI-Device Identifier00883873784969
UDI-Public00883873784969
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K943301
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 06/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11996
Device Catalogue Number11996-000017
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2022
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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