FDA Adverse Event
Malfunction
Summary report: N
CAREFUSION
MDR report key: 4749063
·
Received May 1, 2015
Report
- Report Number
- 2021710-2015-00894
- Event Type
- Malfunction
- Date Received
- May 1, 2015
- Date of Event
- April 6, 2015
- Report Date
- April 6, 2015
- Manufacturer
- CAREFUSION
- Product Code
- LSZ
- PMA / PMN Number
- P890057
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CAREFUSION FAILURE ANALYSIS TECH WILL EVALUATE THE ALLEGED FAILED PART IF IT IS RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE AMPLITUDE IS LOW ON THE PERFORMANCE CHECK. THE PT CALIBRATION CAME OUT OK. HE CHECKED THE PNEUMATICS AND FOUND THAT HE COULD NOT ADJUST THE BIAS FLOW METER TO 60. NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289197 | CAREFUSION | LSZ | CAREFUSION | 3100B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |