FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ SCHANNEL 3.01
MDR report key: 4102394
·
Received August 27, 2014
Report
- Report Number
- 9615050-2014-04993
- Event Type
- Malfunction
- Date Received
- August 27, 2014
- Date of Event
- August 2, 2014
- Report Date
- August 7, 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
- GA, 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
DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN A PROXIMAL OCCLUSION WAS PRESENT. PRIOR TO TESTING, THE DEVICE HAD BEEN RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT OF NO DISPLAY. NO INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518928 | SYMBIQ SCHANNEL 3.01 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |