FDA Adverse Event
Malfunction
Summary report: N
3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
MDR report key: 5356007
·
Received January 8, 2016
Report
- Report Number
- 2021710-2016-02653
- Event Type
- Malfunction
- Date Received
- January 8, 2016
- Date of Event
- December 14, 2015
- Report Date
- December 14, 2015
- Manufacturer
- CAREFUSION
- Product Code
- LSZ
- PMA / PMN Number
- P890057
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CAREFUSION COMPLAINT NUMBER (B)(4). THE CAREFUSION FIELD SERVICE REPRESENTATIVE EVALUATED THE UNIT BUT WAS UNABLE TO REPRODUCE THE REPORTED EVENT. THE FIELD SERVICE REPRESENTATIVE PERFORMED THE CIRCUIT CALIBRATION AND PERFORMANCE CHECKS AND RUN ON THE PERFORMANCE CHECK SETTINGS FOR AN HOUR. ALL TESTS PASSED. THE UNIT IS WORKING PER MANUFACTURER SPECIFICATIONS. IN THE EVENT ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. THE CUSTOMER DID NOT STATE IF THE UNIT WAS ON A PATIENT AT THE TIME OF THE EVENT. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE UNIT STOPPED AND WAS UNABLE TO GET IT STARTED AGAIN. THE CUSTOMER DID NOT STATE IF THE UNIT WAS ON A PATIENT AT THE TIME OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 14306 | 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) | VENTILATOR, HIGH FREQUENCY | LSZ | CAREFUSION | 3100A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |