FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ SINGLE CHANNE
MDR report key: 4102376
·
Received August 27, 2014
Report
- Report Number
- 9615050-2014-04986
- Event Type
- Malfunction
- Date Received
- August 27, 2014
- Date of Event
- July 25, 2014
- Report Date
- July 29, 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
- AL, 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 DEVICE WAS RETURNED TO THE SERVICE CTR FOR A REPORT FROM THE CUSTOMER CONTACT OF AN S208 (CAN BUS ERROR -PSC) ERROR CODE. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CTR, THE DEVICE ALARMED WITH AN S321 (MOTOR ERROR - PMC, LEFT) MALFUNCTION ALARM CODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522508 | SYMBIQ SINGLE CHANNE | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |