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 2019-01-23 for GIRAFFE OMNIBED 6650-0004-901 manufactured by Ohmeda Medical.
[133838775]
Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[133838776]
The unit went into alleged "fan failure" alarm shortly after the patient, a (b)(6) early newborn, was placed in the omnibed in the incubator position. Because of the fan failure alarm, the customer had to move the patient from one bed to another. The customer stated that once the patient was moved, the infant required a chest tube and then ventilation on the evening of (b)(6). On (b)(6), the patient passed away.
Patient Sequence No: 1, Text Type: D, B5
[140031461]
A ge healthcare service representative performed a checkout of the system but did not confirm the reported issue. Ge healthcare product engineering performed an investigation of this event. The fan failure alarm can get triggered when the fan is not pushed down far enough onto the rubber hub. Giraffe omnibed cleaning & care guidelines (m1131904 rev a) covers the proper reassembly instructions of the fan after cleaning. Ge healthcare engineering determined that it is likely that the improper seating of fan or fan hub contributed to the intermittent "¿? Fan failure alarm¿?. " the biomed stated that this problem is noticed sporadically with other giraffe omnibeds in the nicu as well after the fan assembly was dis-assembled and re-assembled after cleaning. Therefore, the probable root cause for the intermittent fan failure alarm could be fan or fan hub not seated properly by the hospital staff. The infant's status was fragile and unstable from time of delivery and throughout the time in the nicu. The infant was intubated prior to the move to the new bed. After the move, the patient continued to de-saturate and required a chest tube. The unit raised the fan failure alarm as designed. Therefore, the giraffe omnibed did not cause or contribute to the infant demise.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121732-2019-00001 |
| MDR Report Key | 8270167 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-23 |
| Date of Report | 2019-03-22 |
| Date of Event | 2018-12-25 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-01-23 |
| 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 |
| Generic Name | NEONATAL INCUBATOR |
| Product Code | FMZ |
| Date Received | 2019-01-23 |
| Model Number | 6650-0004-901 |
| 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 | 1. Death | 2019-01-23 |