MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for BILIBLANKET PLUS HIGH OUTPUT 6600-0656-801 manufactured by Ohmeda Medical.
[110231559]
Patient Sequence No: 1, Text Type: N, H10
[110231560]
Light was flashing and alerted infant's mother that unit was overheating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7573101 |
| MDR Report Key | 7573101 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-05-16 |
| Report Date | 2018-05-22 |
| Date Reported to FDA | 2018-05-22 |
| Date Reported to Mfgr | 2018-05-22 |
| Date Added to Maude | 2018-06-06 |
| 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 | BILIBLANKET PLUS HIGH OUTPUT |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2018-06-06 |
| Catalog Number | 6600-0656-801 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHMEDA MEDICAL |
| Manufacturer Address | 8880 GORMAN RD LAUREL MD 20723 US 20723 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-06 |