FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2792494
·
Received October 16, 2012
Report
- Report Number
- 1416980-2012-02494
- Event Type
- Malfunction
- Date Received
- October 16, 2012
- Date of Event
- September 25, 2012
- Report Date
- September 26, 2012
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915523
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN AND THE CONDITION WAS CONFIRMED. THE CAUSE WAS DETERMINED TO BE DAMAGE TO THE POWER CORD. TO CORRECT THE CONDITION, THE POWER CORD WAS REPLACED.
Description of Event or Problem · 1
A FLOGARD DEVICE WAS RETURNED FOR PREVENTATIVE MAINTENANCE. DURING INITIAL INSPECTION, THE BAXTER TECHNICIAN FOUND A BROKEN POWER CORD. THE CUSTOMER DID NOT ALLEGE ANY PRODUCT MALFUNCTION OR DEFECT. THE PROCESS STEP IS UNKNOWN. THERE WAS NO PATIENT INVOLVED; THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |