FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ DCHANNEL 3.01
MDR report key: 3963565
·
Received May 30, 2014
Report
- Report Number
- 9615050-2014-03744
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- January 1, 2014
- Report Date
- April 8, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K110901
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE MECHANISM 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 DEVICE MECHANISM WAS RETURNED TO THE SERVICE CTR WITH A REPORT FROM THE CUSTOMER OF AN S420 (PLUNGER HOMING TIMEOUTS) MALFUNCTION ALARM CODE. NO ADDITIONAL INFO WAS PROVIDED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CTR, THE DEVICE ALARMED WITH AN S421 (MOTOR ERROR-PMC, RIGHT) MALFUNCTION ALARM CODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319793 | SYMBIQ DCHANNEL 3.01 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |