FDA Adverse Event
Death
Summary report: N
ENDOTRACHEAL TUBE/HI VOLUME/LOW PRESS./CUFFED
MDR report key: 1627578
·
Received February 25, 2010
Report
- Report Number
- 9611710-2010-00001
- Event Type
- Death
- Date Received
- February 25, 2010
- Date of Event
- January 26, 2010
- Report Date
- February 2, 2010
- Manufacturer
- UNOMEDICAL SDN BHD
- Product Code
- BTR
- PMA / PMN Number
- K951696
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4)
Description of Event or Problem · 1
REPORTED BY THE COMPLAINANT AS FOLLOWS... A FEW DAYS AGO A DISTURBING INCIDENT HAPPENED WHEREBY THE ICU TEAM NOTICED A PROBLEM WITH PT WHO WAS ON THE RESPIRATOR DUE TO THE SATURATION ASSESSMENTS WHICH WERE EXTREMELY LOW. THE HEAD NURSE SAID THAT AT A CERTAIN POINT, THE DOCTOR CHECKED THE ETT WITHIN THE THROAT AND REALIZED THAT IT HAD TWISTED ITSELF AND THAT A NEW INTUBATION PROCEDURE HAD TO BE PERFORMED. A FEW DAYS LATER, A SIMILAR EVENT OCCURRED WHEREBY THE ETT TWISTED. RIGHT AFTERWARDS THE PT'S CONDITION BEGAN TO DETERIORATE. THE PT PASSED AWAY A SHORT WHILE AFTER THE OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTRACHEAL TUBE/HI VOLUME/LOW PRESS./CUFFED | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | UNOMEDICAL SDN BHD | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |