MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for GIRAFFE OMNIBED CARESTATION CS1 manufactured by Datex-ohmeda, Inc.
[182729867]
During routine inspections of the datex-ohmeda/ge giraffe omnibed care station infant incubators, we have started noticing small cracks on the surface of the foot section acrylic panel (please see pictures attached). The cracks are mostly seen around the stress points where the acrylic is molded. The concern is about future breaks on those areas if the cracks keeps developing onto bigger dents. It could cause possible injury to users and could be a risk to patients. So far, no injuries or incidents have happened, we are replacing those acrylics with new ones, a po (purchase order) to ge was issued for the new parts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9810747 |
| MDR Report Key | 9810747 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-25 |
| Report Date | 2020-03-02 |
| Date Reported to FDA | 2020-03-02 |
| Date Reported to Mfgr | 2020-03-10 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | GIRAFFE OMNIBED CARESTATION |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2020-03-10 |
| Model Number | CS1 |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATEX-OHMEDA, INC |
| Manufacturer Address | 3030 OHMEDA DRIVE MADISON WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |