FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ DUAL CHANNEL
MDR report key: 4152578
·
Received October 6, 2014
Report
- Report Number
- 9615050-2014-05502
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Date of Event
- January 1, 2014
- Report Date
- September 17, 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
- HI, 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
DURING TESTING, AT START UP, THE DEVICE DISPLAYED A HW (HARDWARE) WATCHDOG ERROR. FURTHER TESTING FOUND A S136 (WATCHDOG ERROR - UIC) MALFUNCTION ALARM CODE IN THE DEVICE HISTORY. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN 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 |
|---|---|---|---|---|---|---|---|
| 622198 | SYMBIQ DUAL CHANNEL | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |