FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3073135
·
Received April 23, 2013
Report
- Report Number
- 1416980-2013-10091
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Report Date
- April 2, 2013
- Manufacturer
- SHARP CORPORATION OSAKA JAPAN
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED DURING DEVICE EVALUATION BY A SERVICE TECHNICIAN. THE FORCE SENSING RESISTORS (FSRS)WERE FOUND TO BE DAMAGED. THE FSRS WERE RESOLVE THE ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT ALARMED FAILURE CODE 38. IT IS UNKNOWN IN WHICH CARE AREA OR THE PROCESS STEP THAT THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION RELATED TO THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174796 | FLOGARD | PUMP, INFUSION | FRN | SHARP CORPORATION OSAKA JAPAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |