FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ 3.13 SINGLE C
MDR report key: 4143027
·
Received September 12, 2014
Report
- Report Number
- 9615050-2014-05221
- Event Type
- Malfunction
- Date Received
- September 12, 2014
- Date of Event
- January 1, 2014
- Report Date
- September 3, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K110901
- Removal / Correction Number
- Z-0069-2013
- 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 TOUCH POINTS ON THE TOUCHSCREEN WERE FOUND TO BE OFF CENTER. THIS WAS DUE TO THE TOUCHSCREEN BEING OUT OF CALIBRATION. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THE DEVICE TOUCHSCREEN WAS OUT OF CALIBRATION. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE TOUCH POINTS ON THE TOUCHSCREEN WERE OFF CENTER WHEN PRESSED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565202 | SYMBIQ 3.13 SINGLE C | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |