MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-14 for MEDISORB MULTI ABSORBER 8003138 * manufactured by Datex-ohmeda.
[15687362]
Prior to the patient entering the operating room, a routine anesthesia machine check was performed and the machine was fully functional. The patient was brought to the or. During induction of anesthesia, the anesthesia technician changed the multi absorber. An endotracheal tube, ett, was placed by the anesthesiologist and confirmation of the ett placement in the trachea was made by bilateral breath sounds and positive end-tidal co2. Within moments, elevated peak inspiratory pressures were noted. Medications were given, ett was removed and patient was ventilated by mask. The patient was re-intubated, and had one more episode of the same circumstances. A chest x-ray was done and was negative. The ett was again removed, and patient ventilated by mask. The ett was replaced again, and there was one more episode of same problems described above. The surgery was cancelled. The patient was awakened and taken to recovery. The patient was subsequently discharged home. There were no sequelae noted. Later while an anesthesia technician was cleaning the or room, it was discovered that microfoam was taped on 2 bottom openings of the multi absorber.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 583647 |
| MDR Report Key | 583647 |
| Date Received | 2005-03-14 |
| Date of Report | 2005-02-24 |
| Date of Event | 2005-02-16 |
| Report Date | 2005-02-24 |
| Date Reported to FDA | 2005-03-14 |
| Date Added to Maude | 2005-03-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDISORB MULTI ABSORBER |
| Generic Name | CO2 ABSORBER, DISPOSABLE |
| Product Code | BSF |
| Date Received | 2005-03-14 |
| Model Number | 8003138 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 573474 |
| Manufacturer | DATEX-OHMEDA |
| Manufacturer Address | P.O. BOX 7550 MADISON WI 53707 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-14 |