FDA Adverse Event
Other
Summary report: N
UNI-VENT
MDR report key: 2451058
·
Received February 4, 2012
Report
- Report Number
- 2242630-2012-00004
- Event Type
- Other
- Date Received
- February 4, 2012
- Report Date
- January 21, 2012
- Manufacturer
- IMPACT INSTRUMENTATION, INC.
- Product Code
- BTA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DATE NOTIFIED: (B)(6) 2012. A MODEL 73X VENTILATOR (S/N (B)(4)) WAS RECALLED DUE TO THE POSSIBILITY OF INCORRECT TUBING. AN INSPECTION OF THE DEVICE REVEALED LOW PRESSURE TUBING IN AN APPLICATION WHERE HIGH PRESSURE TUBING WAS REQUIRED. THE TUBING WAS REPLACED, THE DEVICE WAS TESTED TO SPECS AND RETURNED TO THE CUSTOMER. NO DEATH OR INJURY RESULTED FROM THE DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNI-VENT | VENTILATOR | BTA | IMPACT INSTRUMENTATION, INC. | 73X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |