MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-06 for AIRBORNE 750I INFANT * manufactured by International Biomedical, Ltd..
[20364282]
A newborn was in transit to the nicu in the device. As the nurse entered the room with the device, the top portion of the device started to slide off the base. The nurse immediately stopped and removed the newborn from the device. The newborn was transported in arms the rest of the way into the room and placed in the warmer. The device was removed from service and sent to biomed for examination. Biomed determined that the 4 bolts that hold the top portion of the device had come loose. The loose bolts were replaced. The bolts are located near shock absorbers, which may have contributed to the loose bolts. Our biomed team determined that the bolts should be added to the 6 month preventative maintenance schedule for this device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4591765 |
| MDR Report Key | 4591765 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-03-06 |
| Date of Event | 2014-12-07 |
| Report Date | 2015-03-06 |
| Date Reported to FDA | 2015-03-06 |
| Date Reported to Mfgr | 2015-03-11 |
| Date Added to Maude | 2015-03-11 |
| 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 | 3 |
| 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 | AIRBORNE 750I INFANT |
| Generic Name | INCUBATOR, NEONATAL TRANSPORT |
| Product Code | FPL |
| Date Received | 2015-03-06 |
| Model Number | 750I |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL BIOMEDICAL, LTD. |
| Manufacturer Address | 8508 CROSS PARK DRIVE AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-06 |