FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ SINGLE CHANNE
MDR report key: 4096239
·
Received August 20, 2014
Report
- Report Number
- 9615050-2014-04868
- Event Type
- Malfunction
- Date Received
- August 20, 2014
- Date of Event
- January 1, 2013
- Report Date
- August 26, 2013
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K110901
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 CUSTOMER CONTACT REPORTED THAT THE QEP COUNT WAS HIGH ON THE MECHANISM READING. THIS DID NOT INDICATE A REPORTABLE MALFUNCTION. THE DEVICE MECHANISM WAS RETURNED. THE DEVICE MECHANISM WAS RETURNED TO THE SERVICE CENTER; HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, USING A TEST DEVICE, THE PUMP ALARMED WITH S321 (MOTOR ERROR) ALARM MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 503772 | SYMBIQ SINGLE CHANNE | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |