FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ SINGLE CHANNE
MDR report key: 3201604
·
Received June 26, 2013
Report
- Report Number
- 9615050-2013-01744
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- January 1, 2013
- Report Date
- May 28, 2013
- Manufacturer
- HOSPIRA HOLDINGS DE COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K110901
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- BIOMEDICAL ENGINEER
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 THAT DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY AFTER THE DEVICE WAS POWERED ON, THE DEVICE ALARMED WITH A WHITESCREEN ERROR. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290747 | SYMBIQ SINGLE CHANNE | 80FRN | FRN | HOSPIRA HOLDINGS DE COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |