FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ DUAL CHANNEL
MDR report key: 4152597
·
Received October 6, 2014
Report
- Report Number
- 9615050-2014-05506
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Date of Event
- January 1, 2014
- Report Date
- September 16, 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 MECHANISM 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 THAT CHANNEL A OF THE DEVICE WITH S321 (MOTOR ERROR - PMC, LEFT) MALFUNCTION ALARM CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NOT REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN USE. DURING TESTING AT THE USER FACILITY, PMC, LEFT) MALFUNCTION ALARM CODE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622149 | SYMBIQ DUAL CHANNEL | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |