FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3260012
·
Received August 1, 2013
Report
- Report Number
- 1416980-2013-20369
- Event Type
- Malfunction
- Date Received
- August 1, 2013
- Date of Event
- July 8, 2013
- Report Date
- July 8, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915523
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VE
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE ROOT CAUSE OF THE F-66 ALARM WAS DETERMINED TO BE A CRACKED CENTRAL PROCESSING UNIT (CPU) BOARD. TO CORRECT THE CONDITION, THE CPU BOARD 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 ON-SITE SERVICE BY A FIELD SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP EXPERIENCED THE F-66 ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359474 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |