MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-18 for BILISOFT manufactured by Ohmeda Medical.
[142400994]
Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. Patient information: contact reports there is no patient information available. Device evaluated by mfr: device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[142400995]
The hospital reported they observed a baby with symptoms of a low temperature burn. A doctor judged that skin change was caused by pressure on the body for a long time. It was reported that the patient recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121732-2019-00019 |
| MDR Report Key | 8528634 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-18 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-03-17 |
| Date Mfgr Received | 2019-07-16 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-04-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN SZALINSKI |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BILISOFT |
| Generic Name | NEONATAL PHOTOTHERAPY UNIT |
| Product Code | LBI |
| Date Received | 2019-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Other | 2019-04-18 |