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 2018-06-19 for GIRAFFE OMNIBED CARESTATION 2082844-001-508846 manufactured by Ohmeda Medical.
[111607482]
Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed. Patient information could not be obtained due to country privacy laws. Unique device identifier: (b)(4). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[111607483]
The hospital alleged that the patient received overheating/burn while in the giraffee omnibed carestation. The system was being used in open warmer mode/baby mode. The hospital has been using baby mode only with probes placed into the patient diapers. Reportedly, the patient overheated and was cooled down, stabilized, and received higher fluids. It is suspected that the overheating occurred because of poor contact between the body and the probe which may cause an incorrect temperature reading and overshot of the power of infrared heater. The warmer was replaced.
Patient Sequence No: 1, Text Type: D, B5
[114560586]
A gehc service representative performed a checkout of the unit in baby mode, as a radiant warmer, for 24 hours. The unit was found to function within manufacturer? S specifications. As stated in the user manual, when using the radiant warmer in "baby mode? , the system requires the baby? S temperature to be measured on the skin of the infant using the temperature probe. This probe is to be properly attached on the abdomen area using a heat reflective patch and in the path of the radiant heat. In this instance, the hospital reportedly used the giraffe omnibed cs in baby mode with the probe placed in the infant? S diapers. Probes, when placed inside the diapers, may not make proper contact with the baby? S skin. An incorrectly applied skin probe with the probe not touching the infant skin can result in incorrect read-out (lower) of the baby temperature by the system. This improper placement may increase the radiant heater power output, resulting in the reported complaint. The cause of the reported complaint is user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121732-2018-00001 |
| MDR Report Key | 7616584 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-19 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-06-22 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2018-06-19 |
| 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 |
| 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 | GIRAFFE OMNIBED CARESTATION |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2018-06-19 |
| Model Number | 2082844-001-508846 |
| ID Number | SEE BLOCK H10 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-19 |