| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GIRAFFE OMNIBED | NEONATAL INCUBATOR | OHMEDA MEDICAL | FMZ | 6650-0004-901 | * | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-03-26 | 0 | 1. D |
Patient 1
GE HEALTHCARE (B)(4) INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. THE CUSTOMER CONTACT REPORTED THERE IS NO PATIENT INFORMATION AVAILABLE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Patient 1
THE HOSPITAL REPORTED THAT THE PATIENT DIED DURING USE OF THIS DEVICE. IT WAS ALSO REPORTED THAT THE HEATER ON THE DEVICE WAS NOT WORKING. THE HOSPITAL DOES NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.
Patient 1
PATIENT AGE PROVIDED. THE PATIENT WAS A (B)(6) WEEK NEONATE THAT WAS (B)(6) DAY OLD. THE PATIENT WAS EXTREMELY PREMATURE, WITH UNDERLYING CONDITIONS. WHEN THE PATIENT WAS ADMITTED TO THE GIRAFFE OMNIBED THE HOOD FAILED TO RAISE UP. THE PATIENT WAS UNSTABLE AND THE HEALTHCARE PROVIDER DECIDED TO KEEP THE PATIENT IN THE GIRAFFE OMNIBED WITH THE HOOD DOWN USING INCUBATOR MODE TO MAINTAIN THE DESIRED TEMPERATURE INSTEAD OF MAINTAINING TEMPERATURE VIA RADIANT HEAT WITH THE HOOD UP. THE HEALTHCARE PROVIDER MAINTAINED THE DESIRED TEMPERATURE VIA INCUBATOR MODE, BUT THE PATIENT PASSED AWAY. THE NEONATAL INTENSIVE CARE UNIT NURSE MANAGER INFORMED GE HEALTHCARE (GEHC) THAT THE BED DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. THE INCUBATOR IS OWNED BY (B)(6) AND WAS BEING RENTED BY (B)(6) HOSPITAL. (B)(6), WAS NOTIFIED THAT THE CANOPY STOPPED WORKING. (B)(6) ADVISED GEHC THAT "THE UNIT HAS BEEN TESTED AND IT WAS FOUND THAT THE CANOPY IS NOT RAISING FULLY WHICH WILL CAUSE THE (RADIANT) HEATER NOT TO ENGAGE." GEHC PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. POSSIBLE CAUSES FOR THE CANOPY NOT MOVING UP COULD BE - BELT, CABLE HARNESS, CANOPY MOTOR, ELECTRICAL COMPONENT, FOOT SWITCH, LOOSE CONNECTION, MEMBRANE SWITCH, RAIL/CANOPY LIFT. (B)(6) DOES NOT HAVE A SERVICE AGREEMENT WITH GEHC FOR THE SERVICE/MAINTENANCE OF THE GIRAFFE OMNIBED. (B)(6) USES THEIR OWN REPAIR SHOP FOR SERVICE AND MAINTENANCE OF THE UNIT. (B)(6) HAS NOT MADE A REQUEST FOR GEHC TO INSPECT OR TEST THE GIRAFFE OMNIBED. THEREFORE, THE ROOT CAUSE FOR THIS INVESTIGATION IS "UNDETERMINED"?.