FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ FRENCH SINGLE
MDR report key: 4152579
·
Received October 6, 2014
Report
- Report Number
- 9615050-2014-05503
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Date of Event
- August 28, 2014
- Report Date
- September 18, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K110901
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE MECHANISM HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 THAT DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, A S321 (MOTOR ERROR - PMC, LEFT) SERVICE ALARM CODE WAS NOTED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622148 | SYMBIQ FRENCH SINGLE | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |