MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-12 for SMITHS MEDICAL PORTEX CUFF PRESSURE MONITORING PRESSUREEASY 292004 manufactured by Smiths Medical Asd, Inc..
[141817329]
Two possible lots were reported for this incident: 3673558 or 3677999.
Patient Sequence No: 1, Text Type: N, H10
[141817330]
Information was received that while a smiths medical endotracheal tube was in use, patient lost lung recruitment and oxygen saturation levels dropped to low 40s. A leak was noted around the cuff, requiring 3 ml of air into the cuff to stop the leak. It was reported patient had severe ards, requiring 20 of peep and sating of mid 80s. It was reported that no injury had occurred to patient as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-01992 |
| MDR Report Key | 8510854 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-04-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 6250 SHIER RINGS ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL PORTEX CUFF PRESSURE MONITORING PRESSUREEASY |
| Generic Name | CUFF, TRACHEAL TUBE, INFLATABLE |
| Product Code | BSK |
| Date Received | 2019-04-12 |
| Catalog Number | 292004 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |