FDA Adverse Event
Malfunction
Summary report: N
SYMBIQ SCHANNEL 3.01
MDR report key: 4102390
·
Received August 27, 2014
Report
- Report Number
- 9615050-2014-04998
- Event Type
- Malfunction
- Date Received
- August 27, 2014
- Date of Event
- January 1, 2014
- Report Date
- August 21, 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
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY, DURING TESTING A REVIEW OF THE DEVICE HISTORY INDICATED A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE. THE PROBABLE CAUSE OF THE S233 MALFUNCTION ALARM CODE WAS A BROKEN FAN. 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 DEVICE ALARMED WITH A S233 (OVER TEMPERATURE- PSC) MALFUNCTION ALARM CODE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, A S233 MALFUNCTION ALARM CODE WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 519011 | SYMBIQ SCHANNEL 3.01 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |