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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 PM35MN
Device Problems Failure to Charge (1085); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  malfunction  
Event Description
During end tidal co2 monitoring, the capnography device alerted "low battery" on display. The respiratory therapist (rcp) attempted to plug the unit into ac power to charge. After several hours the battery did not charge. The rcp tested the charger on another unit and the charging icon on the device presented itself. Defective unit removed from patient and unit secure for biomedical repair. Biomedical noted several other units with the same battery not charging issue. Our medical center currently has 7 units out for warranty repair with this same failure. Battery in use is a 7. 2vdc 19. 24wh liion battery. Manufacturer response for portable respiratory monitor, capnostream 35 (per site reporter) manufacturer received 6 additional unit for warranty repair with same issue.
 
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Brand NameCAPNOSTREAM 35
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
MEDTRONIC
710 medtronic pkwy
minneapolis MN 55432
MDR Report Key12195731
MDR Text Key262495333
Report Number12195731
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPM35MN
Device Catalogue NumberPM35MN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2021
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer07/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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