FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ DUAL CHANNEL
MDR report key: 4180527
·
Received October 15, 2014
Report
- Report Number
- 9615050-2014-05630
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 24, 2014
- Report Date
- September 25, 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
- MN, 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 THE DEVICE ALARMED WITH AN AUDIBLE ALARM AND DISPLAYED A WHITESCREEN ERROR. 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 |
|---|---|---|---|---|---|---|---|
| 655643 | SYMBIQ DUAL CHANNEL | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |