FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ DUALCHAN INF
MDR report key: 3880382
·
Received April 8, 2014
Report
- Report Number
- 9615050-2014-02548
- Event Type
- Malfunction
- Date Received
- April 8, 2014
- Date of Event
- January 1, 2014
- Report Date
- March 10, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K110901
- Removal / Correction Number
- Z-0070-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE DEVICE TOUCHSCREEN WAS FOUND TO BE OUT OF CALIBRATION. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED DURING ANNUAL PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE TOUCHSCREEN COULD NOT BE CALIBRATED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210896 | SYMBIQ DUALCHAN INF | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |