FDA Adverse Event
Malfunction
Summary report: N
THE BELMONT RAPID INFUSER
MDR report key: 7915746
·
Received September 27, 2018
Report
- Report Number
- 1219702-2018-00033
- Event Type
- Malfunction
- Date Received
- September 27, 2018
- Date of Event
- August 17, 2018
- Report Date
- September 27, 2018
- Manufacturer
- BELMONT INSTRUMENT LLC
- Product Code
- LGZ
- UDI-DI
- 10896128002012
- PMA / PMN Number
- K091855
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE UNIT HAS NOT BEEN RETURNED FOR INVESTIGATION AND WE ARE THEREFORE UNABLE TO DETERMINE THE ROOT CAUSE OF THE BLANK DISPLAY. WE HAVE FOLLOWED UP WITH THE USER FACILITY FOR ADDITIONAL INFORMATION AND TO REQUEST THAT THE UNIT BE SENT BACK FOR EVALUATION. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT AFTER THE DEVICE WAS PRIMED AND READY FOR USE THE SCREEN WENT BLANK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 755281 | THE BELMONT RAPID INFUSER | THERMAL INFUSION FLUID WARMER | LGZ | BELMONT INSTRUMENT LLC | FMS 2000 | 10896128002012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |