FDA Adverse Event
Other
Summary report: N
IMPACT
MDR report key: 2439215
·
Received January 30, 2012
Report
- Report Number
- 2242630-2012-00005
- Event Type
- Other
- Date Received
- January 30, 2012
- Date of Event
- December 6, 2011
- Report Date
- January 27, 2011
- Manufacturer
- IMPACT INSTRUMENTATION, INC.
- Product Code
- BTA
- PMA / PMN Number
- K820331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
FILING REPORT AS A DEVICE MALFUNCTION ON A LIFE SUPPORT DEVICE. DATE COMPANY WAS NOTIFIED BY THE END USER: (B)(4), 2012. A MODEL 305GR PORTABLE ASPIRATOR (S/N: (B)(4)) FAILED TO OPERATE. AN INSPECTION OF THE DEVICE REVEALED A DEFECTIVE CIRCUIT BREAKER. THE CIRCUIT BREAKER WAS REPLACED, THE DEVICE WAS TESTED TO SPECS AND WILL BE RETURNED TO THE CUSTOMER. NO DEATH OR INJURY WAS REPORTED DUE TO THE DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPACT | PORTABLE ASPIRATOR | BTA | IMPACT INSTRUMENTATION, INC. | 305 GR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |