MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-14 for GE MULTI ABSORBER, DISPOSABLE manufactured by Ge.
[19960349]
Item: ge - general electric-multi absorber, disposable. We have had approx 5 of these co2 absorber units arrive with cracks in the plastic, which have caused leakage of anesthetic/o2 gases from the anesthesia machine, in some cases, severe enough to prevent adequate ventilation of the pt. This device is the co2 absorber for use with the ge healthcare s/5 avance anesthesia machine. Although no pts have been harmed as a result of this, the potential for pt harm exists. The cause of the cracks are not known , however, i suspect they occur during the shipping process. Since the plastic case is somewhat thin and flimsy, i suspect that a better protective case may be needed for shipping 6 to the case. The cracks have occurred in different parts of the absorber, and do not appear to be the direct result of a manufacturing defect or design defect. A warning message on the cannister to examine carefully for cracks and test with positive pressure prior to use may be helpful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003483 |
| MDR Report Key | 899935 |
| Date Received | 2007-08-14 |
| Date of Report | 2007-08-14 |
| Date of Event | 2007-08-14 |
| Date Added to Maude | 2007-09-05 |
| 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 | GE MULTI ABSORBER, DISPOSABLE |
| Generic Name | CO2 ABSORBER |
| Product Code | BSF |
| Date Received | 2007-08-14 |
| ID Number | REF 8003138 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 880782 |
| Manufacturer | GE |
| Manufacturer Address | GREAT BRITAIN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-08-14 |