MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for VOYAGER INFANT TRANSPORT INCUBATOR manufactured by International Biomedical, Ltd..
[108945763]
Patient Sequence No: 1, Text Type: N, H10
[108945764]
Risk: while on neonatal intensive care unit (nicu) transport, the ventilator in the transporter spontaneously went into system failure, which caused the respiratory therapist to have to bag the baby to keep her ventilated for the remainder of the transport. The isolette then lost power in the ambulance causing the heat to turn off. The respiratory therapist also could not get the mechanism that heats/humidifies the air for the ventilator to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7534426 |
| MDR Report Key | 7534426 |
| Date Received | 2018-05-22 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-01-18 |
| Report Date | 2018-04-17 |
| Date Reported to FDA | 2018-04-17 |
| Date Reported to Mfgr | 2018-04-17 |
| Date Added to Maude | 2018-05-22 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOYAGER INFANT TRANSPORT INCUBATOR |
| Generic Name | INCUBATOR, NEONATAL TRANSPORT |
| Product Code | FPL |
| Date Received | 2018-05-22 |
| Model Number | VOYAGER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-05-22 |