FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ DCHANNEL 3.01
MDR report key: 4152417
·
Received October 3, 2014
Report
- Report Number
- 9615050-2014-05482
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Date of Event
- January 1, 2014
- Report Date
- September 16, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K110901
- 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
THE CUSTOMER CONTACT REPORTED THE DEVICE HAD A WHITESCREEN - SOFTWARE ERROR. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, AFTER THE PUMP WAS POWERED ON, THE DEVICE ALARMED WITH A WHITESCREEN ERROR. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 617550 | SYMBIQ DCHANNEL 3.01 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |