MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for LO-PRO TRACHEAL TUBE CUFFED, MURPHY EYE manufactured by Mallinckrodt Inc..
[12592]
Patient undergoing surgery for brain tumor in posterior fossa. Pt. Was in prone position and the head immobilized with tongs. 31/2 hours into the procedure, airway pressure were noted to increase and a suction catheter would not pass through the endotracheal tube. Direct visualization of oropharynx revealed kink in e. T. Tube. Tube removed and pt. Reintubated. Large kink noted in tube after removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 22530 |
| MDR Report Key | 22530 |
| Date Received | 1994-02-04 |
| Date of Report | 1993-12-21 |
| Date of Event | 1993-11-29 |
| Date Facility Aware | 1993-11-29 |
| Report Date | 1993-12-21 |
| Date Reported to Mfgr | 1993-12-21 |
| Date Added to Maude | 1995-06-19 |
| 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 | LO-PRO TRACHEAL TUBE CUFFED, MURPHY EYE |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | LNZ |
| Date Received | 1994-02-04 |
| ID Number | SIZE 7.0MM I.D. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22709 |
| Manufacturer | MALLINCKRODT INC. |
| Manufacturer Address | P.O. BOX 500600 ST. LOUIS MO 631500600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1994-02-04 |