FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2973046
·
Received February 21, 2013
Report
- Report Number
- 1416980-2013-04413
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 28, 2013
- Report Date
- January 28, 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). 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 BATTERY LOW ALARM WAS DETERMINED TO BE THAT THE BATTERY DEPLETED BELOW THRESHOLD. TO CORRECT THE CONDITION, THE BATTERY WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.
Description of Event or Problem · 1
DURING PRODUCT EVALUATION BY A SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE A BATTERY LOW ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76968 | FLOGARD | PUMP, INFUSION | FRN | SHARP CORPORATION OSAKA JAPAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |