FDA Adverse Event
Other
Summary report: N
ULTRA-LITE
MDR report key: 1695394
·
Received May 18, 2010
Report
- Report Number
- 2242630-2010-00025
- Event Type
- Other
- Date Received
- May 18, 2010
- Report Date
- April 24, 2010
- Manufacturer
- IMPACT INSTRUMENTATION, INC.
- Product Code
- BTA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DATE NOTIFIED: (B)(6) 2010 A MODEL 321 ASPIRATOR (S/N (B)(4)) FAILED TO OPERATE TO SPECIFICATIONS. AN INSPECTION OF THE DEVICE REVEALED A DEFECTIVE VACUUM PUMP. THE VACUUM PUMP WAS REPLACED, THE DEVICE WAS TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. NO PATIENT WAS INVOLVED AT THE TIME OF THE DEVICE FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRA-LITE | ASPIRATOR | BTA | IMPACT INSTRUMENTATION, INC. | 321 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |