MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-12-19 for GIRAFFE OMNIBED CARESTATION 2082844-001 manufactured by Ohmeda Medical.
[131382625]
Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. (b)(4). Device evaluation anticipated, but not yet begun
Patient Sequence No: 1, Text Type: N, H10
[131382626]
The hospital reported that a patient fell out of the warmer. It was further reported that the patient suffered no permanent injury.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1121732-2018-00018 |
MDR Report Key | 8181523 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2018-12-19 |
Date of Report | 2018-12-19 |
Date of Event | 2018-11-19 |
Date Mfgr Received | 2018-11-19 |
Device Manufacturer Date | 2016-09-16 |
Date Added to Maude | 2018-12-19 |
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 |
Reporter Occupation | BIOMEDICAL ENGINEER |
Health Professional | 3 |
Initial Report to FDA | 3 |
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 | GIRAFFE OMNIBED CARESTATION |
Generic Name | INCUBATOR, NEONATAL |
Product Code | FMZ |
Date Received | 2018-12-19 |
Model Number | 2082844-001 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
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 | 2018-12-19 |