MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-27 for MEDISORB M1173310 * manufactured by Ge Healthcare.
[4042958]
There have been multiple defective leaking units with the multi absorber medisorb. These multiple defective leaking units have contributed to anesthesia leakage. The manufacturer has pulled the associated lot from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3499032 |
| MDR Report Key | 3499032 |
| Date Received | 2013-11-27 |
| Date of Report | 2013-11-27 |
| Date of Event | 2013-08-23 |
| Report Date | 2013-11-27 |
| Date Reported to FDA | 2013-11-27 |
| Date Reported to Mfgr | 2013-12-04 |
| Date Added to Maude | 2013-12-04 |
| 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 | 0 |
| 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 |
| Generic Name | ABSORBER, CARBON-DIOXIDE |
| Product Code | BSF |
| Date Received | 2013-11-27 |
| Model Number | M1173310 |
| Catalog Number | * |
| Lot Number | LOT#13030 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 9900 INNOVATION DRIVE MAIL STOP RP-2138 WAUWATOSA WI 53226 US 53226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-27 |