FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3092894
·
Received May 3, 2013
Report
- Report Number
- 1416980-2013-11319
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- March 5, 2013
- Report Date
- April 18, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION. THE CUSTOMER REPORTED PROBLEM OF AN UNDETERMINED SERVICE CODE WAS CONFIRMED BY THE QUALITY ENGINEER AS A FAILURE CODE 49. THE MAIN BATTERY WAS FOUND TO BE DAMAGED AND WAS REPLACED TO RESOLVE THE ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT PRESENTED AN UNDETERMINED SERVICE CODE. IT IS UNKNOWN IN WHICH CARE AREA OR 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 |
|---|---|---|---|---|---|---|---|
| 194567 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |