MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI BEDSIDE SLEEP CAPNOGRAPH; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Catalog Number	9004050
Medical Device Problem Codes	No Display/Image (1183); Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.Device evaluation: one device was returned for investigation.Visual inspection found the rear line is damaged.Functional testing found the device was not getting a etco2 reading via a simulator.Only getting a co2 pump flow rate of approx.4 ml/min.Swapped out the co2 pump and now getting a flow rate of approx.167 mlmin.Device is powering down.Monitor failed battery life test in approx.2 minutes.The complaint was confirmed.Root cause was attributed to a faulty co2 pump and depleted backup power battery.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.Replace faulty co2 pump and depleted backup power battery.
Event or Problem Description
It was reported that the device was not giving accurate readings.Sometimes no readings at all.Intermittently the display will go blank as well.Patient involvement is unknown.

• Brand Name: BCI BEDSIDE SLEEP CAPNOGRAPH
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19326034
• Report Number: 3012307300-2024-03750
• Device Sequence Number: 11405269
• Product Code: CCK
• UDI-Device Identifier: 10610586036866
• UDI-Public: (01)10610586036866(11)100702
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K970209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9004050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown