FDA Adverse Event
Other
Summary report: N
HUMIDIFIER 500 ML STERILE WATER
MDR report key: 360921
·
Received November 16, 2001
Report
- Report Number
- 1419377-2001-00003
- Event Type
- Other
- Date Received
- November 16, 2001
- Report Date
- November 16, 2001
- Manufacturer
- AUTOMATIC LIQUID PACKAGING, INC.
- Product Code
- BTT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHEN TAB IS TORN OFF INLET PORT NUMBER OF HUMIDIFIER BOTTLE IT DOES NOT ALWAYS PRODUCE A HOLE THAT IS CIRCULAR BUT RATHER OVAL IN SHAPE CAUSING O2 TO LEAK AT THE FITTING CONNECTION. INFANTS USE LOW FLOW AMOUNTS (1/32 TO 1/4 LPM) AND MAY CAUSE DESATURATION, HOWEVER, MONITOR HOOK-UP IS BACK UP AND DIRECTIONS FOR USE OF THIS UNIT SHOULD BE READ AND ADMINISTERED CORRECTLY, POSSIBLY CAUSING THE OPENING TEAR INSTEAD OF "SNAP OFF" AS DIRECTIONS STATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52000 | HUMIDIFIER 500 ML STERILE WATER | HUMIDIFIER BOTTLE | BTT | AUTOMATIC LIQUID PACKAGING, INC. | 2620 | 1E060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Hospitalization |