MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-15 for CLIC ABSORBER 800+ MX00004 manufactured by Drager Medical.
[4500527]
The clic absorber 800+ cannister on the anesthesia machine was defective - creating a ventilator leak with potential to harm pt. Problem identified before reaching pt. You are able to look directly down in the cannister and see the white material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036130 |
| MDR Report Key | 3820257 |
| Date Received | 2014-05-15 |
| Date of Report | 2014-05-13 |
| Date of Event | 2014-05-04 |
| Date Added to Maude | 2014-05-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLIC ABSORBER 800+ |
| Generic Name | CO2 SCRUBBER |
| Product Code | BSF |
| Date Received | 2014-05-15 |
| Catalog Number | MX00004 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAGER MEDICAL |
| Manufacturer Address | LUBECK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-15 |