FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 4170313
·
Received October 14, 2014
Report
- Report Number
- 1416980-2014-35810
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- September 19, 2014
- Report Date
- September 19, 2014
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT NO: (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN AS PART OF PREVENTATIVE MAINTENANCE. DURING VISUAL INSPECTION A DAMAGED BATTERY IDENTIFIED; THE CAUSE COULD NOT BE DETERMINED. TO CORRECT THE CONDITION, THE BATTERY WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING PRODUCT SERVICE BY A SERVICE TECHNICIAN, A FLOGARD INFUSION PUMP WAS OBSERVED WITH A DAMAGED BATTERY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 648869 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |