MAUDE Adverse Event Report: CAPNOSTREAM 35; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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.

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.

• Brand Name: CAPNOSTREAM 35
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• MDR Report Key: 12195731
• MDR Text Key: 262495333
• Report Number: 12195731
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM35MN
• Device Catalogue Number: PM35MN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2021
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1