MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2014-08-28 for FEATHER-FLEX ADULT ANESTHESIA CIRCUIT OL-608030-52 manufactured by Bomimed Inc..
[4696645]
After extended use (over 4 hours), the filter within the breathing circuit assembly became saturated. This resulted in increased airway pressures over 40cmh20. When the filter was changed, the airway pressures dropped to 20cmh20 (a normal level).
Patient Sequence No: 1, Text Type: D, B5
[12199395]
Circuit kit ol-608030-52 is not sold to u. S. Customers (only (b)(4) customers). The filter within this kit is ol-04750-00. This filter is sold to u. S. Customers. Device listing #d002125, 510 k851070. Upon request, no pt info was provided by the hospital.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003213883-2014-00001 |
| MDR Report Key | 4098326 |
| Report Source | 00,01 |
| Date Received | 2014-08-28 |
| Date of Report | 2014-08-06 |
| Date of Event | 2014-07-07 |
| Date Mfgr Received | 2014-07-07 |
| Date Added to Maude | 2014-09-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TRINA FRIESEN |
| Manufacturer Street | 96 TERRACON PL. |
| Manufacturer City | WINNIPEG, MANITOBA R2J 4G7 |
| Manufacturer Country | CA |
| Manufacturer Postal | R2J 4G7 |
| Manufacturer Phone | 6332664 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEATHER-FLEX ADULT ANESTHESIA CIRCUIT |
| Generic Name | BREATHING CIRCUIT |
| Product Code | BSJ |
| Date Received | 2014-08-28 |
| Model Number | OL-608030-52 |
| Catalog Number | OL-608030-52 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOMIMED INC. |
| Manufacturer Address | WINNIPEG, MANITOBA CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-28 |