FDA Adverse Event
Malfunction
Summary report: N
VENTURI MASK KIT ADULT
MDR report key: 667564
·
Received January 19, 2006
Report
- Report Number
- 9680866-2006-00001
- Event Type
- Malfunction
- Date Received
- January 19, 2006
- Date of Event
- November 23, 2005
- Report Date
- January 17, 2006
- Manufacturer
- UNOMEDICAL INC.
- Product Code
- BYF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IN 2005 UNOMEDICAL'S OFFICIAL CORRESPONDENT REC'D A COMPLAINT FROM QA TECHNICIAN. REC'D A COMPLAINT OVER A DEFECTIVE VENTURI MASK KIT. NO INCIDENT OCCURRED DUE TO VIGILANCE BY THE NURSING PERSONNEL. THE PROBLEM WAS A PART OF THE VENTURI MASK KIT WAS NOT PERFORATED WHICH RESULTED IN THE VENTURI MASK KIT NOT FEEDING THE INTENDED OXYGEN CONCENTRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTURI MASK KIT ADULT | VENTURI MASK KIT ADULT | BYF | UNOMEDICAL INC. | 3120-E | 05-28 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |