FDA Adverse Event
Malfunction
Summary report: N
CAREFUSION
MDR report key: 4961477
·
Received July 29, 2015
Report
- Report Number
- 2021710-2015-01274
- Event Type
- Malfunction
- Date Received
- July 29, 2015
- Date of Event
- June 15, 2015
- Report Date
- July 1, 2015
- Manufacturer
- CAREFUSION
- Product Code
- CBK
- PMA / PMN Number
- K032451
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A RETURNED GOODS AUTHORIZATION (RGA) NUMBER WAS ALSO ISSUED FOR THE RETURN OF THE ALLEGED FAULTY MAIN PRINTED CIRCUIT BOARD FOR EVALUATION. AS OF 07/29/2015, CAREFUSION HAS YET TO RECEIVE THE ALLEGED FAULTY MAIN PRINTED CIRCUIT BOARD.
Description of Event or Problem · 1
THIS COMPLAINT ORIGINATED FROM A FOREIGN DISTRIBUTOR IN (B)(6): THE DISTRIBUTOR REPORTED A UNIT THAT ALARMED "MOTOR FAULT"/VENT INOP WHEN TURNED ON. ACCORDING TO THE DISTRIBUTOR, THE EVENT LOG DISPLAYED THE FOLLOWING DETAIL: "POST DAC OR ADC ERROR". THEY CHECKED THE DC OUTPUT FROM THE POWER SUPPLY PRINTED CIRCUIT BOARD (PC) AND THAT WAS OKAY. THEY REPLACED THE MAIN PRINTED CIRCUIT BOARD, AND THAT FIXED THE ISSUE. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 492290 | CAREFUSION | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | CAREFUSION | VELA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |