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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 Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 12/22/2021
Event Type  malfunction  
Event Description
Rn responded to etco2 monitor alarming. The monitor was alarming 'battery low". The clinician noted that the charging cord was plugged into the unit, but alarm was still occurring. Rn contacted respiratory therapy to have monitor replaced. Respiratory informed the rn that they would have to locate a replacement due to several units in repair for the same failure. Respiratory exchanged with legacy monitor and patient monitoring continued without additional actions. Monitor removed from service and sent to biomedical engineering for repair and reporting. Biomedical engineering confirmed that when known good charger connector inserted into monitor the battery charge icon on the monitor front panel would not illuminate. This report is a re-occurring event with the same failure. Unit in service for less than 4 months and was actually a replacement for a monitor with the same failure issue.
 
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Brand NameCAPNOSTREAM 35
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
MEDTRONIC
710 medtronic parkway ne
minneapolis MN 55432
MDR Report Key13141533
MDR Text Key283089079
Report Number13141533
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 12/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 FDA12/29/2021
Device Age8 MO
Event Location Hospital
Date Report to Manufacturer01/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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