FDA Adverse Event
Malfunction
Summary report: N
PORTEX SECUREEASY ENDOTRACHEAL TUBE HOLDER
MDR report key: 3003809
·
Received March 11, 2013
Report
- Report Number
- 3003809
- Event Type
- Malfunction
- Date Received
- March 11, 2013
- Date of Event
- February 9, 2013
- Report Date
- March 6, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- CBH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IA, US
Narratives
Description of Event or Problem · 1
PATIENT PREMATURELY EXTUBATED DUE TO BREAK IN HEADGEAR DEVICE. PATIENT WAS VENTILATED WITH BAG MASK AND OXYGEN. PATIENT UNABLE TO MAINTAIN ADEQUATE VENTILAORY STATUS. ANESTHESIA WAS NOTIFIED AND PATIENT RE-INTUBATED. PATIENT RETURNED TO VENTILATOR SUPPORT AND VITALS RETURNED TO BASELINE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PATIENT WAS INTUBATED ON THE VENTILATOR. ET TUBE HOLDER BROKE. PT WAS PLACED ON THE VENT 1/31. EVENT HAPPENED 2/9.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101727 | PORTEX SECUREEASY ENDOTRACHEAL TUBE HOLDER | ENDOTRACHEAL TUBE HOLDER | CBH | SMITHS MEDICAL ASD, INC. | 6242003 | 2259240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | THE PATIENT WAS INTUBATED ON THE VENTILATOR| LONG-TERM ANTIBIOTICS| CARDIAC DRUGS |