FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3760086
·
Received April 18, 2014
Report
- Report Number
- 1416980-2014-12698
- Event Type
- Malfunction
- Date Received
- April 18, 2014
- Date of Event
- March 26, 2014
- Report Date
- March 26, 2014
- Manufacturer
- SHARP CORPORATION OSAKA JAPAN
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. THE DEVICE WAS VISUALLY INSPECTED, FUNCTIONALLY TESTED AND THE ALARM LOG WAS REVIEWED. THE BATTERY LOW ALARM OCCURRED DURING A BATTERY TEST. THE CAUSE OF THE BATTERY LOW ALARM WAS NOT DETERMINED. TO CORRECT THE CONDITION, THE 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
DURING PRODUCT SERVICE BY A SERVICE TECHNICIAN, A FLOGARD INFUSION PUMP PRESENTED A BATTERY LOW ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237340 | FLOGARD | PUMP, INFUSION | FRN | SHARP CORPORATION OSAKA JAPAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |