FDA Adverse Event
Injury
Summary report: N
SALTER LABS
MDR report key: 372560
·
Received January 17, 2002
Report
- Report Number
- MW1023860
- Event Type
- Injury
- Date Received
- January 17, 2002
- Date of Event
- October 12, 2001
- Manufacturer
- SALTER LABS
- Product Code
- BTT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ADD'L INFO REC'D FROM RPTR 12/18/01: SOME TESTING WAS CONDUCTED ON THE WATER BY A PRIVATE LAB.
Description of Event or Problem · 1
OXYGEN BUBBLE HUMIDIFIER BOTTLE EXHIBITS CLOUDY WATER (CHEMICAL CLOUD) WHEN DISTILLED WATER IS USED IN BOTTLE AND BOTTLE IS RUN ON MULTIPLE CONCENTRATORS OR LIQUID O2 TANKS AT 4-6 LITERS/MIN FOR 12 HOURS OR MORE OR CONTINUOUS. SIX (6) BOTTLES IN CONTROLLED TESTING ON HOME HEALTH CARE EQUIPMENT (ALL) EXHIBIT ANOMALY; BOTTLE HAS A (FOGGED) FINISH AND IT IS IMPOSSIBLE TO SEE THE WATER WHEN IN USE. MUST POUR OUT INTO CLEAR CONTAINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SALTER LABS | OXYGEN BUBBLE HUMIDIFIER BOTTLE | BTT | SALTER LABS | * | NO22 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | 1) OXYGEN CONCENTRATOR.| 2) LIQUID OXYGEN RESERVOIR TANKS (3). |