FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 4250259
·
Received November 14, 2014
Report
- Report Number
- 1416980-2014-40261
- Event Type
- Malfunction
- Date Received
- November 14, 2014
- Date of Event
- October 21, 2014
- Report Date
- November 4, 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
(B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. VISUAL INSPECTION, POWER ON SELF TESTING, AND A REVIEW OF THE ALARM LOG WERE PERFORMED. THE DAMAGED POWER CORD WAS IDENTIFIED DURING VISUAL INSPECTION. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. TO CORRECT THE CONDITION, THE POWER CORD 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 FOUND TO HAVE A DAMAGED POWER CORD. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738211 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |