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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CAPNOSTREAM 35; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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MEDTRONIC CAPNOSTREAM 35; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number CAPNOSTREAM 35
Device Problem Failure to Charge (1085)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
Event Type  malfunction  
Event Description
During setup and use of an etco2 monitor, the therapist noted an alarm icon on the display with a red battery next to the battery charge indicator.The therapist also noted that the green battery charge icon on the devices front panel was not powered on indicating that the battery was not charging.The device was removed from the care area and sent to biomedical engineering for repair and reporting action.This is a repeating failure we have observed on this model capnograph of which we have previously reported under medwatch.Manufacturer response for monitor, portable respiratory, capnostream 35.This is a reoccurring event reported to both medwatch and the equipment manufacturer.Root cause still in progress.
 
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Brand Name
CAPNOSTREAM 35
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
MEDTRONIC
8200 coral sea street ne
mounds view MN 55112
MDR Report Key14117563
MDR Text Key289347144
Report Number14117563
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCAPNOSTREAM 35
Device Catalogue NumberPM35MN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/04/2022
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer04/15/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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