MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-29 for THE BELMONT RAPID INFUSER FMS 2000 903-00001 manufactured by Belmont Medical Technologies.
[146268707]
Following receipt of the complaint, belmont's national sales manager and director of r&d and engineering visited the hospital and met with the hospital biomed. The unit was observed and it was determined that the source was the power cord and not the unit itself. The c19 connector was incinerated, which was the source of the soot covering the back of the system. It was noted that there was lint, dried saline, and debris inside the intake air openings. The unit was opened and there was no damage noted to the internal components. The system was subsequently turned on in battery mode, as the power cord was compromised. The unit powered up normally and all the key features were within specification. The manufacturing records for this serial number were reviewed and nothing notable was found. The routine maintenance schedule provided in the operator's manual instructs the user: "inspect the fan guards, on the bottom of the unit, for debris that might impede air flow. Remove guards by unscrewing the 4 retaining screws and clean, with soap and water, if necessary. Make certain the guards are not damaged. Let the fan guards dry before reinstalling. " it was reported that there was no injury to the patient. Should additional information become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[146268708]
The trauma nurse from the user facility reported the following: "the belmont machine was turned on and the tubing put in place and primed. The machine was turned off and a few minutes later the machine caught on fire and was put out by the staff with a fire extinguisher. " it was reported that the patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219702-2019-00018 |
| MDR Report Key | 8466861 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2019-03-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SABRINA BELLADUE |
| Manufacturer Street | 780 BOSTON ROAD |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 9783307637 |
| Manufacturer G1 | BELMONT MEDICAL TECHNOLOGIES |
| Manufacturer Street | 780 BOSTON ROAD |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE BELMONT RAPID INFUSER |
| Generic Name | THERMAL INFUSION FLUID WARMER |
| Product Code | LGZ |
| Date Received | 2019-03-29 |
| Model Number | FMS 2000 |
| Catalog Number | 903-00001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BELMONT MEDICAL TECHNOLOGIES |
| Manufacturer Address | 780 BOSTON ROAD BILLERICA MA 01821 US 01821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |