MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-07 for BCI CAPNOCHECK II CAPNOGRAPH MONITOR 8401 manufactured by Smiths Medical Asd, Inc..
[176242221]
Device evaluation: one bci monitor device was received for investigation in good condition. The monitor was powered on and it was found that the display was blank. Adjustment of the display contrast also did not change the screen. However, upon installation of a new main board and lcd connector, the display became legible. Based on the investigation and testing, the complaint was confirmed. The display issue was noted to be a result of impact sustained by the monitor during use and handling. The evaluation noted that the protective boot around the device housing acts as shock absorber, preventing damage to the housing. However, pressure to the display and centrifugal forces in the time of impact affects pixel alignment in the lcd grid, known for resulting in pixels damage. It was also stated that the operation manual informs the user in chapter 1 & 3 in the warning section with the following information: "any monitor that has been dropped or damaged, should be inspected by qualified service personnel, prior to use, to insure proper operation. "
Patient Sequence No: 1, Text Type: N, H10
[176242222]
Information was received that a smiths medical bci capnocheck ii capnograph monitor had a blank display. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00046 |
| MDR Report Key | 9560621 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date Mfgr Received | 2019-12-10 |
| Device Manufacturer Date | 2011-06-30 |
| Date Added to Maude | 2020-01-07 |
| 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 II CAPNOGRAPH MONITOR |
| Generic Name | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| Product Code | CCK |
| Date Received | 2020-01-07 |
| Returned To Mfg | 2019-03-22 |
| Model Number | 8401 |
| Catalog Number | 8401 |
| 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 | 2020-01-07 |