FDA Adverse Event
Malfunction
Summary report: N
CAREFUSION
MDR report key: 4999436
·
Received August 11, 2015
Report
- Report Number
- 2021710-2015-01378
- Event Type
- Malfunction
- Date Received
- August 11, 2015
- Date of Event
- July 16, 2015
- Report Date
- July 16, 2015
- Manufacturer
- CAREFUSION
- Product Code
- CBK
- PMA / PMN Number
- K032451
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CAREFUSION FAILURE ANALYSIS TECHNICIAN WILL EVALUATE THE ALLEGED FAILED PART IF IT IS RETURNED TO THE MFR.
Additional Manufacturer Narrative · 1
THE CAREFUSION FAILURE ANALYSIS TECHNICIAN EVALUATED THE MAIN PCBA INSTALLED IN KNOWN GOOD UNIT, POWERED ON IN SERVICE MODE AND VIEW EVENT ERROR LOG, NOTICE MULTIPLE 24V POWER SUPPLY VOLTAGE TOO LOW WITH POST DAC OR ADC ERROR¿S. POWERED UNIT IN OPERATING MODE AND INSTANTLY FAILED VENT INOP WITH MOTOR FAULT. FINDINGS/ROOT-CAUSE: REPORTED PROBLEM WAS DUPLICATED AND ISOLATED TO BAD 100K RESISTOR R608. THE ISSUE IS BEING ADDRESSED IN INTERNAL CORRECTION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN THE POWER WAS ON, "OPERATION FAILURE" AND "MOTOR FAILURE" ALARMS OCCURRED. NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 527774 | CAREFUSION | CBK | CAREFUSION | VELA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |