FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ SINGLE CHANNE
MDR report key: 4210826
·
Received August 1, 2014
Report
- Report Number
- 9615050-2014-04662
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Date of Event
- July 11, 2014
- Report Date
- July 15, 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS 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, DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE FAN WAS EXCESSIVELY LOUD AND AN OVER TEMPERATURE MALFUNCTION ALARM CODE WAS NOTED IN THE DEVICE HISTORY LOG. THE SPECIFIC ALARM CODE WAS NOT SPECIFIED. 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 |
|---|---|---|---|---|---|---|---|
| 451895 | SYMBIQ SINGLE CHANNE | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |