FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3242437
·
Received July 23, 2013
Report
- Report Number
- 1416980-2013-19415
- Event Type
- Malfunction
- Date Received
- July 23, 2013
- Report Date
- June 13, 2013
- 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). (B)(6). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. A VISUAL INSPECTION FOUND NO PHYSICAL DAMAGE ON THE DEVICE. WHILE TRYING TO REVIEW THE ALARM LOG, THE DEVICE ALARMED F-49. THE REPORTED ISSUE OF THE DEVICE NOT FUNCTIONING WAS CONFIRMED AS THE F-49 ALARM. THE CAUSE OF THE ALARM WAS DETERMINED TO BE A DEFECTIVE MAIN BATTERY. TO CORRECT THE CONDITION, THE MAIN 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
IT WAS REPORTED THAT A FLOGARD INFUSION PUMP DID NOT FUNCTION. THIS REPORT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342475 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |