FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3013219
·
Received March 20, 2013
Report
- Report Number
- 1416980-2013-06725
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Report Date
- February 18, 2013
- Manufacturer
- SHARP CORPORATION OSAKA JAPAN
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED DURING ON-SITE DEVICE EVALUATION. IT WAS IDENTIFIED THAT THE MOTOR COUPLINGS WERE LOOSE; HOWEVER, THE ROOT CAUSE IS UNKNOWN. THE MOTOR SET SCREWS WERE TIGHTENED TO RESOLVE THE REPORTED CONDITION ADDITIONAL INFORMATION: THE EXACT OCCURENCE DATE IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT DOES NOT INFUSE. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116796 | FLOGARD | PUMP, INFUSION | FRN | SHARP CORPORATION OSAKA JAPAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |