MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-05 for LMT NOMAG IC 3.0 0100022-C manufactured by Lammers Medical Technology America, Inc..
[3195028]
It was observed by users that water from the incubator's humidifier bottle drips through the unit's bottom chassis and directly onto its ac plug and the outlet of the unit's power pack. The dripping water is unavoidable and happens when installing or especially removing the humidifier bottle in its receptacle. The incubator's bottom chassis plate is perforated, and below it in the transport frame is the large box holding batteries and circuitry to generate 120 volts ac during transport. The humidifier bottle is almost directly above the plug and outlet of the battery pack. Water from the bottle pours through the chassis plate and onto the top of the battery box where some pours over the edge directly into the 120-volt ac outlet, or water may drip directly onto the ac plug if the incubator is shifted slightly from its intended position. (prominent arrow labels show intended position, but it is easy to shift a few inches from that. ) some form of canopy or other protection is needed to keep the dripping water away from the 120-volt plug and outlet on the battery box. What was the original intended procedure? Product is used to maintain a warm, humidified environment for infants during mr imaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2996450 |
| MDR Report Key | 2996450 |
| Date Received | 2013-03-05 |
| Date of Report | 2013-03-05 |
| Date of Event | 2013-03-05 |
| Report Date | 2013-03-05 |
| Date Reported to FDA | 2013-03-05 |
| Date Reported to Mfgr | 2013-03-11 |
| Date Added to Maude | 2013-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LMT NOMAG IC 3.0 |
| Generic Name | INCUBATOR, NEONATAL TRANSPORT, MRI COMPATIBLE |
| Product Code | FPL |
| Date Received | 2013-03-05 |
| Model Number | LMT NOMAG IC 3.0 |
| Catalog Number | 0100022-C |
| Lot Number | * |
| ID Number | * |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAMMERS MEDICAL TECHNOLOGY AMERICA, INC. |
| Manufacturer Address | 3407 ANTONY DR. BROADVIEW HEIGHTS OH 44147 US 44147 |
| Brand Name | LMT NOMAG TR |
| Generic Name | INCUBATOR, NEONATAL TRANSPORT, TROLLEY |
| Product Code | FPL |
| Date Received | 2013-03-05 |
| Model Number | LMT NOMAG TR |
| Catalog Number | 0600047-B |
| Lot Number | * |
| ID Number | * |
| Device Age | 3 MO |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | LAMMERS MEDICAL TECHNOLOGY AMERICA, INC. |
| Manufacturer Address | * * * |
| Brand Name | LMT NOMAG PP |
| Generic Name | INCUBATOR, NEONATAL TRANSPORT, BATTERY PACK |
| Product Code | FPL |
| Date Received | 2013-03-05 |
| Model Number | LMT NOMAG PP |
| Catalog Number | 0800102-B |
| Lot Number | * |
| ID Number | * |
| Device Age | 3 MO |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | LAMMERS MEDICAL TECHNOLOGY AMERICA, INC. |
| Manufacturer Address | 3407 ANTONY DR BROADVIEW HEIGHTS OH 44147 US 44147 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-05 |