MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-18 for CALEO INCUBATOR manufactured by Draego Medical Inc..
[3687677]
As i prepared to test an incubator from nicu last week (b)(6) 2013), i plugged the unit into an outlet after changing a fuse. There was a sputtering sound, and then light flashes and smoke poured out of openings in the incubator. I quickly unplugged the unit and watched the device for some time to be sure there was no residual fire. I opened the housing a few days later after smoke settled inside and discovered the cause was accumulated residue of baby formal that had found a way into a high voltage area that should be protected from such entry (df). Event (b)(4) reported to psn as an unsafe condition on (b)(6) 2013. The results are (b)(4) inspections show various degrees of buildup and some damage. The remaining 10 units will be inspected today ((b)(4) 2013). We have tagged the defective units as unsafe. Any device with evidence of fluid intrusion will be removed from service pending drager medical's response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030985 |
| MDR Report Key | 3245035 |
| Date Received | 2013-07-18 |
| Date of Event | 2013-07-05 |
| Date Added to Maude | 2013-07-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALEO INCUBATOR |
| Generic Name | INCUBATOR |
| Product Code | FPL |
| Date Received | 2013-07-18 |
| Returned To Mfg | 2013-07-05 |
| Model Number | CALEO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGO MEDICAL INC. |
| Manufacturer Address | 3135 QUARY ROAD TELFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-18 |