FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2993711
·
Received March 7, 2013
Report
- Report Number
- 1416980-2013-05561
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- October 16, 2012
- Report Date
- October 16, 2012
- Manufacturer
- SHARP CORPORATION OSAKA JAPAN
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED AS FAILURE CODE F-38. THE CAUSE OF THE PROBLEM WAS DETERMINED TO BE FORCE SENSING RESISTORS (FSRS) WHICH WERE OUT OF SPECIFICATION. THE FSRS WERE REPLACED IN ORDER TO CORRECT THE PROBLEM.
Description of Event or Problem · 1
THE FACILITY REPORTED A FLOGARD INFUSION PUMP THAT PRESENTED AN UNDETERMINED MALFUNCTION. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, HOWEVER THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT OR USER INJURY, NOR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98111 | FLOGARD | PUMP, INFUSION | FRN | SHARP CORPORATION OSAKA JAPAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |