MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-13 for BCI CAPNOCHECK SLEEP OXIMETER 9004050 manufactured by Smiths Medical Asd, Inc..
[176671240]
Manufacturing information 2007-12. Device evaluation : one sleep oximeter was received for investigation. The reported complaint was verified after a flow rate on the returned monitor performed. It was found the monitor had no flow. After internally inspecting the monitor, it was found all tubing was contaminated, and tubing was replaced with a new tubing kit. However, the flow rate still was not resolved. Therefore, a new restrictor was installed and the flow rate increased to 166 ml/min (specification: 150 +/- 20 ml/min). Furthermore, the investigation team performed c02 10% hi/low calibration and it was found the c02 readings were at 73 mmhg (specification: 73+/-3 mmhg). Due to more than ten years of service, the main battery and rtc battery were replaced as preventive maintenance. The bottom case was also found with a damaged internal leg that supports the top case and the barrel was found with a crack. Based on the evaluation, the complaint was confirmed. The investigation noted that the found internal tubing contamination and co2 bench clogging was from fluid aspiration and moisture built up over 10 years usage, along with non-functional c02 sleep pump due to wear. Contamination inside the tubing is consistent with fluid aspiration from the patient. The unit's operation manual chapter one on introduction and chapter 6 on pneumatics and co2 calibration cautioned "a bci 21-0450-24 moisture trap must also be used when connecting to the patient. This will prevent ingress of moisture into the monitor" in addition to the filter connecting the rear of the unit".
Patient Sequence No: 1, Text Type: N, H10
[176671241]
Information was received that a smiths medical bci capnocheck sleep oximeter was "not picking up co2". The monitor was not on a patient at the time of the event. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00227 |
| MDR Report Key | 9583234 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BCI CAPNOCHECK SLEEP OXIMETER |
| Generic Name | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| Product Code | CCK |
| Date Received | 2020-01-13 |
| Returned To Mfg | 2019-08-20 |
| Model Number | 9004050 |
| Catalog Number | 9004050 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-13 |