FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ SINGLE CHANNEL
MDR report key: 2861584
·
Received November 28, 2012
Report
- Report Number
- 9615050-2012-01424
- Event Type
- Malfunction
- Date Received
- November 28, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 18, 2012
- 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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED A WHITESCREEN ERROR. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT OF S308 (CAN BUS ERROR-PMC, LEFT) ERROR CODE. NO TRACKING INFO WAS PROVIDED,THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY AFTER THE DEVICE WAS POWERED ON, THE DEVICE ALARMED WITH A WHITESCREEN ERROR. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYMBIQ SINGLE CHANNEL | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |