MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-11 for AIRBORNE 750 A750I M1061999/731-0160 manufactured by International Biomedical.
[20090545]
During transport of a neonate to another care area, the clinician smelled a strong electrical odor coming from the isolette on the side being pushed. The caregiver turned off the power to the isolette and transfered the infant to another isolette. The isolette was sent to biomedical for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020800 |
| MDR Report Key | 2020800 |
| Date Received | 2011-03-11 |
| Date of Report | 2011-03-11 |
| Date of Event | 2011-03-08 |
| Report Date | 2011-03-11 |
| Date Reported to FDA | 2011-03-11 |
| Date Added to Maude | 2011-03-16 |
| 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 | AIRBORNE 750 |
| Generic Name | INTERNAL TRANSPORT INCUBATOR/ISOLETTE |
| Product Code | FPL |
| Date Received | 2011-03-11 |
| Returned To Mfg | 2011-03-14 |
| Model Number | A750I |
| Catalog Number | M1061999/731-0160 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 90 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL BIOMEDICAL |
| Manufacturer Address | 8508 CROSS PARK DRIVE AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-11 |