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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO; ELECTRODE, ELECROCARDIOGRAPH
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PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO; ELECTRODE, ELECROCARDIOGRAPH Back to Search Results
Model Number 11996
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control 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 physio-control to report that their device would not display ecg rhythm when connected to a patient.As a result, device therapy would not be available, if needed.There were no reports of adverse effects to the patient as a result of the reported event.
 
Event Description
A customer contacted physio-control to report that their device would not display ecg rhythm when connected to a patient.As a result, device 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
Physio-control product analysis center (pac) evaluated the electrodes and was unable to duplicate or verify the reported issue.The cause of the reported issue could not be verified.
 
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Brand Name
QUIK-COMBO
Type of Device
ELECTRODE, ELECROCARDIOGRAPH
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key12425401
MDR Text Key269906250
Report Number0003015876-2021-01701
Device Sequence Number1
Product Code DRX
UDI-Device Identifier00883873784945
UDI-Public00883873784945
Combination Product (y/n)N
PMA/PMN Number
K943301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11996
Device Catalogue Number11996-000091
Device Lot Number033933
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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