MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for VOYAGER TRANSPORT INCUBATOR 20035655 manufactured by International Biomedical, Ltd..
[130985937]
Neonatal transport isolette/oxygen delivery-blender device failed during (and prior to) neonatal intensive care unit (nicu) transport. This caused inability to bringing patient back on a low fio2/low flow nasal cannula, which was current therapy ordered. History of event: blender alarm noted upon initial assessment around 10:00 am-prior to leaving the facility on transport. Three additional rts evaluated the blender alarm and came to the conclusion that biomed needed to be involved. Biomed was not immediately available, so engineering came immediately and then was able to involve biomed after further assessment. One of the air regulators was found to have a large leak no matter what troubleshooting was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8183858 |
| MDR Report Key | 8183858 |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-12-06 |
| Report Date | 2018-12-19 |
| Date Reported to FDA | 2018-12-19 |
| Date Reported to Mfgr | 2018-12-20 |
| Date Added to Maude | 2018-12-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOYAGER TRANSPORT INCUBATOR |
| Generic Name | INCUBATOR, NEONATAL TRANSPORT |
| Product Code | FPL |
| Date Received | 2018-12-20 |
| Catalog Number | 20035655 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL BIOMEDICAL, LTD. |
| Manufacturer Address | 8206 CROSS PARK DR AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |