FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3172573
·
Received June 17, 2013
Report
- Report Number
- 1416980-2013-15513
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Report Date
- May 23, 2013
- 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). THE DEVICE WAS SERVICED AT THE CUSTOMER SITE. THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED CONDITION OF CANNOT TURN ON WAS CONFIRMED AS A KEYPAD ISSUE. THE CAUSE OF THE REPORTED CONDITION WAS DUE TO A RIBBON CABLE BEING DISCONNECTED. TO CORRECT THE ISSUE THE RIBBON CABLE WAS RECONNECTED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FLOGARD INFUSION PUMP WAS UNABLE TO TURN ON. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273217 | FLOGARD | PUMP, INFUSION | FRN | SHARP CORPORATION OSAKA JAPAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |